Pharmatech Associates is a well-established, global consulting firm known for deploying technically superior, highly dedicated, professional project teams.  Our Pharmaceutical, Biotech and Medical Device clients are located throughout the USA and Internationally.

We are looking for a Project Manager, GMP Operational Readiness to join our consulting team and provide project leadership. This is a salaried position with bonus and benefits, full-time staff position.

We’re looking for thought leaders who:

  • Provide direct project management services on major GMP facilities including the asset induction, commissioning, validation, and GMP documentation phases.
  • Assume responsibility for project execution, including coordination of technical information, field work, and contracted resources toward achievement of stated goals
  • Possess established influencing abilities, sound judgment and the ability to act effectively/calmly with a high degree of independence.
  • Simultaneously manage a variety of projects and bring them to completion on time, within budget, and safely with a quality mindset.
  • Provide solutions to technical and scheduling conflicts. Identify, evaluate, and implement the use of technology and methods to improve Facilities and Operations.  Remove roadblocks so others can complete their activities and achieve success.
  • Encourage and interact with clients, developing new business relationships, goals and objectives.
  • Coordinate scheduling and logistic plans and assume responsibility for the timely and efficient completion (Project Close-out) of project activities.
  • Track and monitor scheduled activities weekly, utilizing Primavera P6 software.
  • Compile and present monthly updates to client Senior Leadership regarding schedule forecasts, project status, accomplishments, project risks, and key business items requiring decisions.
  • Oversee asset induction, calibration, commissioning, validation, and GMP documentation project phases.  Facilitate weekly meetings, assuring safety and quality of all work performed.
  • Develop and recommend long and short-range plans for improving project timelines to meet project milestones.
  • Facilitate pull-planning and schedule Kaizen meetings.
  • Track, update and/or expedite the flow of information, files, drawings, submittals, and correspondence in support of project activities.
  • Participate in required GMP trainings and site-specific safety trainings.
  • Schedule, facilitate, and distribute meeting minutes with assignable action items.
  • Assist the project manager and construction team in coordinating the schedule of disruptive work and/or Commissioning testing.
  • Manage and mitigate Project Risk (i.e., risk of the facility not being turned over on time, risk to project execution, risk of scope creep, etc.).

Qualifications

  • Bachelor of Science Degree in Engineering or equivalent
  • 8 – 12 years of GMP project management experience in a Pharmaceutical or Biopharmaceutical environment
  • Project management experience of at least 2 relevant new construction or tenant improvement projects greater than $30M.
  • Minimum 3 years’ experience as a Project Manager in a consultative role is required
  • Strong understanding of asset induction, commissioning, process equipment validation, computer systems validation (CSV), GMP documentation required for system GMP release, and Change Controls.
  • Understanding of system start up sequence
  • Project Controls experience would be nice to have
  • Strong understanding of process equipment:  Reactors, filter dryers, isolators, + others
  • Must have excellent demonstrated experience with scheduling software, preferably Primavera P6 software.

 

Client Work Environment

  • Currently work remotely per COVID guidelines
  • Expect 1 to 2 onsite visits per week.

About Pharmatech Associates

At Pharmatech Associates, our mission is to fulfill customer expectations throughout the development and execution of tailored, high value, innovation solutions.  We are committed to fostering an environment that is professional and forth right.  These principles are captured in the values we believe are essential to maintaining our supportive culture and our commitment to our clients’ success. We seek to establish an atmosphere of openness, objectivity, accountability, mutual respect and teamwork so each employee can realize their fullest potential for personal and professional growth. We value work life balance.  At Pharmatech talent matters, and we tackle each project with a “no fear” attitude.  We stand together as a team, and we’ve got your back.  Pharmatech’s commitment to integrity is unwavering.

 

 

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

Auto Draft

Pharmatech Associates is a well-established, global consulting firm known for deploying technically superior, highly dedicated, professional project teams.  Our Pharmaceutical, Biotech and Medical Device clients are located throughout the USA and Internationally.

 

We are looking for a Sr. Validation Engineer/CQV to join our consulting team and provide market leadership, develop and execute science based clinical and regulatory solutions for the Life Science industry.  This is a long term contract position located in N. San Diego area with opportunity to convert to a full time role if desired.

We’re looking for thought leaders who:

  • The Sr. Validation Engineer/CQV, Commissioning, Qualification and Validation will provide CQV services to clients in the Life Sciences Industry and perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project scope.
  • Follows client standards and regulatory requirements, overall good industry practices for commissioning, qualification and validation (CQV) services.
  • This position is primarily responsible for execution of validation activities to drive overall quality and compliance at the assigned client’s facilities and may be part of a larger team executing a specific project scope or may act in a staff augmentation role by executing a variety of validation deliverables.
  • General validation support for equipment installations and modifications.
  • Key skills include creating commissioning and qualification documentation (commissioning and IQ, OQ and PQ protocols), executing commissioning and qualification activities including temperature mapping, authoring summary reports, and supporting any other validation needs related to the project.

KEY ACTIVITIES AND RESPONSIBILITIES

  • Participate in project teams executing various validation projects under the direction of a project manager or validation lead.
  • Participate in issue identification, investigation and mitigation.
  • Provide routine progress and issue updates to project team.
  • Participate in client Validation teams in executing routine Validation deliverables.
  • Be responsible for the development of documentation to support commissioning.
  • Write final reports for IQs, OQs and PQ Protocols for facility, utility, and process equipment.
  • Perform commissioning, qualification, and validation testing on manufacturing process equipment and instruments; authors protocols, initiates controlled documentation, and provides client support for CQV projects either independently or as part of a larger team.
  • Responsibilities may include generation of documents such as master plans, design qualification, equipment, facility and utility commissioning and development and development of final reports.
  • The position requires extensive interaction with clients to identify CQV needs and work towards solutions that meet schedule, cost, and quality expectations and requirements.
  • Reviews equipment specifications, manuals, and develops an understanding of how instruments work; tests equipment accurately to meet requirements for intended use
  • Investigates failures and deviations; creates reports
  • Analyses and reviews spare parts lists to ensure they are fit for purpose
  • Reviews engineering drawings for accuracy and acts to correct errors
  • Performs system walk-downs and makes changes using the change control of processes
  • Initiates and resolves client Corrective and Preventative Actions (CAPAs)
  • Expert understanding and work habits compliant with cGMPs and pharmaceutical and biopharmaceutical unit operations
  • Exceptional writing skills required to author and execute DQ, FAT, SAT, IQ, OQ, PQ, and PV documents, develop SOPs, create final reports and author validation and quality policies, procedures and guidelines
  • A thorough and working knowledge of and ability to apply GMP, GCP, GLP, GAMP and CFR21 Part 11 guidelines to ensure compliance as they relate to qualification of systems and validation of processes
  • Ability to provide self-direction and work independently or on a team
  • Analytical, organizational, time management and problem-solving skills
  • Take a proactive role in supporting CQV projects and in providing client support and build a high level of trust personnel.

QUALIFICATIONS

  • Bachelors degree in a chemical, biomedical or biochemical engineering, biological sciences, or related field plus a minimum of 7 years relevant industry experience
  • Working knowledge of cGMP manufacturing as well as regulatory regulations and requirements for biotechnology, pharmaceuticals and medical devices is required
  • Strong experience with CQV (Commissioning, Qualification, Validation) and quality System/Life Science manufacture industry experience is required.
  • Have solid experience supporting commissioning and qualification projects in the life sciences industry.
  • Understanding of GMP production facility utilities and their application, such as Water for Injection (WFI), Cleanroom Environments (HVAC), Clean Steam and process gases.
  • Experience in temperature mapping is preferred
  • Subject Matter expertise in the following areas:

 

  • Manufacturing and utility systems
  • Facility qualification
  • Equipment qualification

 

  • Ability to think critically and demonstrate troubleshooting and problem-solving skills.
  • Able to function efficiently and independently in a fast paced, changing environment.
  • Able to function and contribute as part of a team.
  • Possess excellent interpersonal, verbal and written communication skills.

 

What you’ll like most about working with our team at Pharmatech Associates:

  • Everyone at Pharmatech Associates contributes to the success of our projects, departments and company.  Your input will not only be heard; it will be encouraged and valued.
  • We are consultants, and you will move from project to project.  You will have endless opportunities to learn and grow your career.
  • Your coworkers are a group of highly intelligent and motivated employees.  There will always be someone in-house that has done the job you were hired to do, and you will be able to learn from them.
  • We take great pride in offering our employees the best benefits and competitive compensation packages in our industry, plus performance-based bonus incentives.
  • Fantastic co-workers and no internal politics!  A culture that thrives on true collaboration.

About Pharmatech Associates

 

At Pharmatech Associates, our mission is to fulfill customer expectations throughout the development and execution of tailored, high value, innovation solutions.  We are committed to fostering an environment that is professional and forth right.  These principles are captured in the values we believe are essential to maintaining our supportive culture and our commitment to our clients’ success. We seek to establish an atmosphere of openness, objectivity, accountability, mutual respect and teamwork so each employee can realize their fullest potential for personal and professional growth. We value work life balance.  At Pharmatech talent matters, and we tackle each project with a “no fear” attitude.  We stand together as a team, and we’ve got your back.  Pharmatech’s commitment to integrity is unwavering.

 

 

 

Auto Draft

Pharmatech Associates is a well-established, global consulting firm known for deploying technically superior, highly dedicated, professional project teams.  Our Pharmaceutical, Biotech and Medical Device clients are located throughout the USA and Internationally.

 

We are looking for a Project Manager, Validation/CQV to join our consulting team and provide market leadership, develop and execute science based clinical and regulatory solutions for the Life Science industry.  This is a long term contract position located in N. San Diego area with opportunity to convert to a full time role if desired.

We’re looking for thought leaders who:

  • The Commissioning, Qualification and Validation (CQV) Project Manager will provide CQV services to clients in the Life Sciences Industry and perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project scope.
  • Follows client standards and regulatory requirements, overall good industry practices for commissioning, qualification and validation (CQV) services.
  • Interfaces directly with clients in the delivery of projects including routine communications, leading project meetings, tracking and reporting project metrics (financial and deliverables), self-directing and directing of assigned project team, maintains positive client relationship, etc.
  • This hands-on project manager position shall be responsible for managing the development and execution of CQV documentation on a variety of equipment, facilities, utilities and systems for a diverse life science client base of biotechnology, pharmaceutical and medical device companies.

KEY ACTIVITIES AND RESPONSIBILITIES

  • Directly responsible for the successful delivery of commissioning and compliance projects to clients.
  • Leads multiple concurrent small, mid-sized, or large projects.
  • Runs meetings, communicates status and project issues with client representative(s), and facilitates general project coordination activities.
  • Ensures all work meets budget requirements and quality standards.
  • Develop project schedules, deliverable tracking reports, scope adjustment notices
  • Support, train, mentor, and provide guidance to commissioning and validation specialists/engineers and project leaders in the delivery of CQV services for assigned projects
  • Assist or take lead in proposal development including scope definition, attend bid meetings, development of hours and cost budgets and proposal presentations
  • Lead the team in generating and executing CQV protocols using Good Documentation Practices (GDPs)
  • Lead execution of CQV testing with support from contractors, engineering and operations
  • Stay current (training, reading, professional organization involvement) with industry trends and current CQV methodologies.
  • This position is client facing with an emphasis on ensuring CQV project deliverables meet schedule, cost, scope, quality, and safety.
  • Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support assorted projects and clients
  • This position will have travel as required by the assigned project.
  • Position may be assigned to client site for an extended period of time.
  • Overnight travel or staying in the city of projects location is possible depending on assignment.
  • Must be self-sufficient and effectively work with limited to no supervision.
  • Make recommendations for possible project and procedural improvements.

QUALIFICATIONS

  • Bachelor’s degree in a life science discipline plus a minimum of 7 years of experience in Pharmaceutical, Biotech or Medical Device industries
  • Experience in writing and execution of IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment and Systems is required
  • Strong knowledge of US FDA (21 CFR 210, 211, 810) regulations
  • General exposure and experience in a GMP/Validation discipline with knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to FDA regulatory requirements and cGMP regulations is required.
  • Experience with Cleaning, Process, Computer System, Methods, and other validation activities and processes is preferred
  • Strong working knowledge of commissioning, qualification and validation deliverables, team building and client relationship building is required
  • Ability to tracking progress according to schedules and cost estimates is required
  • Flexibility and willingness to travel and work at various clients locations is required
  • Project Management Professional (PMP) certification or Professional Engineer (PE) license desirable.
  • Ability to write and manage others in the preparation of CQV documents following established standards and templates, including but not limited to the following:
  • CQV Master Plans
  • Commissioning Test Plans
  • CQV Protocols and Summary Reports
  • Standard Operating Procedures
  • Impact Assessments
  • Specifications (URS/FRS/DDS)FATS/SATs
  • Able to perform and manage others during site activities including, but not limited to, the following:
  • Attend FATs and SATs as a representative of our clients.
  • Execution of commissioning forms and witnessing of vendor start-up and testing.
  • Execution of CQV protocols.
  • Walkdown and verification of system drawings
  • Perform and manage staff in compiling data packages and prepare reports for completed CQV activities.
  • Audit project deliverables to assure compliance with established standards.

What you’ll like most about working with our team at Pharmatech Associates:

  • Everyone at Pharmatech Associates contributes to the success of our projects, departments and company.  Your input will not only be heard; it will be encouraged and valued.
  • We are consultants, and you will move from project to project.  You will have endless opportunities to learn and grow your career.
  • Your coworkers are a group of highly intelligent and motivated employees.  There will always be someone in-house that has done the job you were hired to do, and you will be able to learn from them.
  • We take great pride in offering our employees the best benefits and competitive compensation packages in our industry, plus performance-based bonus incentives.
  • Fantastic co-workers and no internal politics!  A culture that thrives on true collaboration.

About Pharmatech Associates

 

At Pharmatech Associates, our mission is to fulfill customer expectations throughout the development and execution of tailored, high value, innovation solutions.  We are committed to fostering an environment that is professional and forth right.  These principles are captured in the values we believe are essential to maintaining our supportive culture and our commitment to our clients’ success. We seek to establish an atmosphere of openness, objectivity, accountability, mutual respect and teamwork so each employee can realize their fullest potential for personal and professional growth. We value work life balance.  At Pharmatech talent matters, and we tackle each project with a “no fear” attitude.  We stand together as a team, and we’ve got your back.  Pharmatech’s commitment to integrity is unwavering.

 

 

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

 

Pharmatech Associates is a well-established, global consulting firm known for deploying technically superior, highly dedicated, professional project teams.  Our Pharmaceutical, Biotech and Medical Device clients are located throughout the USA and Internationally.

 

We are looking for a Director of Business Development to join our consulting team and provide market leadership, develop and execute science based clinical and regulatory solutions for the Life Science industry.  This is a salaried position with bonus and benefits, full-time staff position.  This person will be responsible for adding to the current overall corporate sales through individual effort, sales program development and supporting the current Pharmatech leadership responsible for sales

Success will be measured through a combination of the following:

  • Follow-up on inbound marketing leads and identify qualified opportunities providing appropriate levels of information at the right time for interested prospects
  • Be responsible for educating and developing prospects leading to hand-off to appropriate sphere Subject Matter Experts
  • Develop a sales and business development process and function within Pharmatech which is scalable as the company grows
  • Gather regular market intelligence which will be used to create a target prospects lists and penetrate key accounts. Intelligence gathering will involve a few activities, including scanning industry press releases, trade magazines, and economic data produced by the government to find out about trends and what Pharmatech’s competition is doing.
  • Profile strategic accounts identifying key individuals, researching, and obtaining business requirements and presenting solutions to start the sales cycle
  • Set appointments for the Pharmatech sales team when a lead reaches a qualified stage
  • Nurture new marketing leads by educating and developing prospects until they are ready to speak with a Pharmatech sales representative
  • Drive attendance for webinars and live seminars, set meetings for conferences
  • Ensure successful follow through of sales cycle by maintaining accurate activity and lead qualification information in CRM application
  • Establishing a budget for business development which can be used to drive sales and strategic growth.
  • Establish key performance indicators (KPIs) for sales and business development. Possible KPIs include: Total Monthly sales, Sales Dollars/Client, sales Dollars/new Client, Sales Dollars/ Existing Client, Sales Dollars/ Service Area
  • Support and contribute to all marketing and branding development activities
  • Realize a year over year growth of $3MM with a four-year objective of $12-15MM in total annual sales
  • Strong understanding of the basic activities for drug development for the US and EU.
  • Familiar with the basic concepts and activities of the core services provided by Pharmatech as it relates to each sphere in the ecosystem
  • Solid understanding of the dynamic market pressures in the US and major global markets for API, pharmaceutical, biologic, gene therapy and medical device, and combination products
  • Be an active member of other sphere projects to assist in supporting internal and external sales activities
  • Consult and advise where needed and when requested, to support all client engagements within the company.
  • The Director of Business Development must be capable of working across all functions of a client’s C-Suite and with their Board of Directors.
  • Identify and target markets with the highest growth potential that align with Pharmatech’s overall service capabilities and develop sales plans that deliver successful engagements with strong revenues.
  • Develop annual financial targets and budgets that will deliver growth along with acceptable levels of revenue and GM to support the company.
  • Actively champion Pharmatech’s culture:  internalizing, understanding, and demonstrating the 7 key attributes of our culture in a continuous manner.
  • This position has full authority and responsibility for maintaining a strong and respectful relationship with all key stake holders within the client account.

 

Qualifications:

  • Master’s Degree preferred or Bachelor with a scientific or engineering-related major is required.
  • Strong leadership skills with at least 10 years of demonstrated leadership and experience in sales development or business development, preferably with experience running a successful and profitable-related consulting or services practice.
  • Demonstrated expertise in digital and virtual sales and business development
  • Demonstrated success in prospecting
  • Previous experience establishing and administering an effective Business Development/Sales Development processes and systems
  • Extremely self-motivated with a diligent work ethic
  • High level of integrity and strong commitment to building a successful company
  • Ability to work independently as well as part of a team in a fast-paced environment
  • Outstanding management skills and demonstrated leadership capabilities with a proven ability to work cross-functionally within client organizations.
  • Able to effectively communicate to various audiences, including C-level and BOD level client personnel.  Exceptionally strong written and oral communications is a must.
  • Strong relationship management skills
  • Capable to travel and work remotely at client sites throughout the United States and internationally.

What you’ll like most about working with our team at Pharmatech Associates:

  • Everyone at Pharmatech Associates contributes to the success of our projects, departments and company.  Your input will not only be heard; it will be encouraged and valued.
  • We are consultants, and you will move from project to project.  You will have endless opportunities to learn and grow your career.
  • Your coworkers are a group of highly intelligent and motivated employees.  There will always be someone in-house that has done the job you were hired to do, and you will be able to learn from them.
  • We take great pride in offering our employees the best benefits and competitive compensation packages in our industry, plus performance-based bonus incentives.
  • Fantastic co-workers and no internal politics!  A culture that thrives on true collaboration.

About Pharmatech Associates

 

At Pharmatech Associates, our mission is to fulfill customer expectations throughout the development and execution of tailored, high value, innovation solutions.  We are committed to fostering an environment that is professional and forth right.  These principles are captured in the values we believe are essential to maintaining our supportive culture and our commitment to our clients’ success. We seek to establish an atmosphere of openness, objectivity, accountability, mutual respect and teamwork so each employee can realize their fullest potential for personal and professional growth. We value work life balance.  At Pharmatech talent matters, and we tackle each project with a “no fear” attitude.  We stand together as a team, and we’ve got your back.  Pharmatech’s commitment to integrity is unwavering.

 

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

 

Pharmatech Associates is a well-established, global consulting firm known for deploying technically superior, highly dedicated, professional project teams.  Our Pharmaceutical, Biotech and Medical Device clients are located throughout the USA and Internationally.

 

We are looking for an Executive Director, Clinical and Regulatory Affairs

to join our consulting team and provide market leadership, develop and execute science based clinical and regulatory solutions for the Life Science industry.  This is a salaried position with bonus and benefits, full-time staff position.

We’re looking for thought leaders who:

  • Provide market segment leadership and subject matter expertise for the Clinical and Regulatory Affairs sphere.
  • Develop and execute science-based clinical and regulatory affairs solutions for the regulated life sciences industry.
  • Must be able to speak to and demonstrate knowledge in the following areas: drugs, biologics, nutraceuticals, homeopathic drugs, IVD, medical devices and combination products as it relates to clinical and regulatory affairs primarily in the US, EU and other international markets
  • Accountable for growing Pharmatech’s Clinical and Regulatory Affairs sphere through sales development, outstanding project management and exceptional client relationship management.
  • As a member of the senior leadership team, participate in strategic and operational decision-making processes necessary for the successful attainment of the organization’s initiatives.
  • Primary responsibility for managing all aspects of Profit & Loss performance including resource allocation, project proposal development, expense control and the development of annual budgets and monthly forecasts.
  • Assemble world-class consulting teams by actively supporting recruitment efforts, including negotiating compensation, and providing growth and mentorship opportunities.
  • Champion and execute Pharmatech’s culture to heighten employee engagement and maximize retention of top talent.  Prepare and communicate annual performance reviews.
  • Maintain an awareness and understanding of changes to Global International regulatory requirements as it relates to current drug therapy categories with the goal of assessing potential impact on current client operations.

 

Qualifications:

  • Bachelor or Master’s Degree with a scientific or engineering related major is required, PhD is a nice to have
  • Strong leadership skills with at least 10 years of demonstrated leadership and experience in the regulatory affairs area within the regulated life sciences industry
  • Strong background in non-clinical and clinical studies is needed
  • Must have experience with eCTD Modules 4 and 5
  • Must be able to understand ICH Guidelines, Quality, Safety, Efficacy and Multidisciplinary guidelines
  • Experience with Monoclonal Antibody, CAR-T and cell/gene therapy
  • Experience running a successful and profitable clinical and regulatory affairs consulting practice is a plus
  • Expertise in following registrations: BLA, IND, NDA, 510K (including De Novo) devices, Pre-Market Approval (PMA) devices, MAF’s, IVD, NDA, ANDA, IND and BLA for pharmaceutical and biotech products
  • Strong technical writing capabilities specific to regulatory activities
  • Outstanding personnel management skills and demonstrated leadership capabilities with a proven ability to work cross-functionally within client organizations
  • Able to effectively communicate to various audiences, including C-level and BOD level client personnel.  Exceptionally strong written and oral communications is a must
  • Capable to travel and work remotely at client sites throughout the United States and internationally

What you’ll like most about working with our team at Pharmatech Associates:

  • Everyone at Pharmatech Associates contributes to the success of our projects, departments and company.  Your input will not only be heard; it will be encouraged and valued.
  • We are consultants, and you will move from project to project.  You will have endless opportunities to learn and grow your career.
  • Your coworkers are a group of highly intelligent and motivated employees.  There will always be someone in-house that has done the job you were hired to do, and you will be able to learn from them.
  • We take great pride in offering our employees the best benefits and competitive compensation packages in our industry, plus performance-based bonus incentives.
  • Fantastic co-workers and no internal politics!  A culture that thrives on true collaboration.

 

About Pharmatech Associates

 

At Pharmatech Associates, our mission is to fulfill customer expectations throughout the development and execution of tailored, high value, innovation solutions.  We are committed to fostering an environment that is professional and forth right.  These principles are captured in the values we believe are essential to maintaining our supportive culture and our commitment to our clients’ success. We seek to establish an atmosphere of openness, objectivity, accountability, mutual respect and teamwork so each employee can realize their fullest potential for personal and professional growth. We value work life balance.  At Pharmatech talent matters, and we tackle each project with a “no fear” attitude.  We stand together as a team, and we’ve got your back.  Pharmatech’s commitment to integrity is unwavering.

 

 

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

 

Pharmatech Associates is a well-established, global consulting firm located in the San Francisco bay area.   We are known for deploying technically superior, highly dedicated, professional project teams.

 

We are looking for an exceptional validation engineer to join our consulting team providing validation services to clients in the regulated life sciences industry.  If you enjoy travel, some of our pharmaceutical, biotech and medical device company clients are located outside of the San Francisco Bay Area.  This is a non-exempt position, full-time, at client sites and responsible for coordination, execution and management of validation deliverables for equipment, critical utilities and processes.

A typical day as Validation Engineer includes:

  • Preparing and executing protocols for equipment, facility, utility, and cleaning validation work (IQ, OQ, PQ, & DQ); preparing final reports to summarize results of the execution
  • Developing and revising new or existing procedures to ensure compliance to cGMP, GLP, FDA and worldwide regulations.
  • Providing technical advice on new equipment and modification to existing equipment to ensure validation/qualification status is maintained in a state of control
  • Following policies and procedures to conform to and maintain compliance with site, corporate and regulatory standards.
  • Coordinating validation activities by constantly communicating with affected departments and personnel

What you’ll like most about working with our Validation & Commissioning team at Pharmatech Associates:

  • Everyone at Pharmatech Associates contributes to the success of our projects, departments and company.  Your input will not only be heard; it will be encouraged and valued.
  • We are consultants, and you will move from project to project.  You will have endless opportunities to learn and for career growth.
  • Your coworkers are a group of highly intelligent and motivated employees.  There will always be someone in-house that has done the job you were hired to do, and you will be able to learn from them.
  • We take great pride in offering our employees the best benefits and competitive compensation packages in our industry, plus performance-based bonus incentives.
  • Fantastic co-workers and no internal politics!  A culture that thrives on true collaboration.

We’re looking for candidates who:

  • Earned a bachelor’s degree in engineering or life sciences
  • Have 3+ years’ validation experience in the regulated life sciences industry
  • Exhibit above-average proficiency with cGMPs, GDP & GEP
  • Good understanding of the validation life cycle and are experienced with IQ, OQ, PQ, DQ protocol generation and execution
  • Demonstrate a know-how of solid dosage process equipment, automation system, facility and utility qualifications and project management
  • Display exceptional communication (written and verbal) and interpersonal skills
  • Are motivated, with the ability to work in a team environment or effectively work independently at client sites
  • Can travel domestically and overnight to client project sites
  • Easily and efficiently use the suite of Microsoft Office products

 

Preferred qualifications:

  • Experience working for a consulting firm
  • Cleaning Validation experience
  • Computer Systems Validation Experience

About Pharmatech Associates:

At Pharmatech Associates, our mission is to fulfill customer expectations throughout the development and execution of tailored, high value, innovation solutions.  We are committed to fostering an environment that is professional and forth right.  These principles are captured in the values we believe are essential to maintaining our supportive culture and our commitment to our clients’ success.   We seek to establish an atmosphere of openness, objectivity, accountability, mutual respect and teamwork so each employee can realize their fullest potential for personal and professional growth. We value work life balance.  At Pharmatech talent matters, and we tackle each project with a “no fear” attitude.  We stand together as a team, and we’ve got your back.  Pharmatech’s commitment to integrity is unwavering.

 

EEOC Statement:

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

 

 

 

At Pharmatech Associates, our mission is to fulfill customer expectations throughout the development and execution of tailored, high value, innovation solutions. We are committed to fostering an environment that is professional and forth right. These principles are captured in the values we believe are essential to maintaining our supportive culture and our commitment to our clients’ success. We seek to establish an atmosphere of openness, objectivity, accountability, mutual respect and teamwork so each employee can realize their fullest potential for personal and professional growth. We value work life balance. At Pharmatech talent matters, and we tackle each project with a “no fear” attitude. We stand together as a team, and we’ve got your back. Pharmatech’s commitment to integrity is unwavering.

 

Responsibilities:

 The Principal Process Engineer must be a resource to the entire company in terms of technical expertise as an associate to the VP of Product Process

  • This position will work closely with the CSO, VP of PPD, and Pharmatech Project Managers to provide statistical analysis, technical and process guidance and training to the organization and to Pharmatech’s On a project basis this individual could also assume project specific management responsibilities.
  • Responsible for identifying opportunities to optimize client’s process technologies and improve quality. This includes data collection and analysis to support new and ongoing process development and scale up
  • Support potential new client sales as a technical expert within the This position will estimate project costs, develop proposals, and ensure adhering to project scope.
  • Develops cost control programs and develops metrics to report project

Job Functions:

 

  • Provide broad based consulting services to regulated life sciences clients; such services will include project management as well as execution of project
  • Serve as a QbD subject matter expert with respect to formulation development, process development, process transfer and scale up, and process validation. This includes solid and liquid dosage forms, liquid and cream products, and biologics including packaging, cGMP systems and
  • Design processes for validation, product/process transfers and continued process verification; including data analysis, gap analysis, identification of critical technical and compliance requirements, technical and compliance documentation review, and process
  • Direct the design and scale-up of pharmaceutical and biotech manufacturing processes, select appropriate instruments and equipment from the laboratory through pilot plant and manufacturing scale-up. Identify opportunities to reduce process variability which includes, but not limited to, conceptualizing and directing equipment solutions and refining /updating procedures and operational checklists and training guides

Qualifications:

  • Bachelor or master’s degree with a scientific or engineering related major is required
  • Minimum of 10 years’ experience required. Experience within a manufacturing environment for FDA regulated products
  • Experience with formal and direct client management in a consulting role
  • Knowledge of Quality Target Product Profile, Critical Quality Attributes, and Critical Process Parameters as well as a working familiarity with Quality by Design (QbD) is essential
  • Must be current and proficient in newly introduced global concepts, practices, and procedures within the regulated life sciences industry
  • Excellent understanding of process design and optimization principles, CMC, root cause analysis methodologies
  • Must be proficient with GDP, GLPs, ICH, CFR, and global regulations as appropriate.
  • Exceptional personnel management skills and demonstrated leadership capabilities with a proven ability to work cross-functionally within client organizations
  • Outstanding English communication (written and verbal) and dynamic interpersonal skills with the ability to work in a team environment and capable of communicating effectively at all levels of management from the executive level (Board of Directors and C-Level) through the operator and analyst
  • Capable to travel and work remotely at client sites throughout the United States and internationally
  • Ability to work in fast pace and demanding environment

 

Essential Job Functions:

 Travel without restrictions up to 20% for business development and to client project sites both domestically and internationally required. Travel to domestic project sites may include reoccurring, short-term, overnight stays. Must be able to sit and stand for long periods of time (minimum 4 hours at a time) and lift a minimum of 30 pounds. Must be able to clearly articulate in English. Must be able to comfortably work in confined spaces and interact face to face with co-workers, client personnel and large groups. Must be able to successfully pass background check and random drug screens.  Ability to work weekends and more than 8 hours per day.

 

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

Pharmatech Associates is a well-established, global consulting firm located in the San Francisco bay area.   We are known for deploying technically superior, highly dedicated, professional project teams.

We are looking for an exceptional senior level validation engineer to join our consulting team providing validation services to clients in the regulated life sciences industry.  If you enjoy travel, some of our pharmaceutical, biotech and medical device company clients are located outside of the San Francisco Bay Area.  This is a salaried position, full-time, at client sites and responsible for coordination, execution and management of validation deliverables for equipment, critical utilities and processes.

A typical day as Senior Validation Engineer includes:

  • Preparing and executing protocols for equipment, facility, utility, and cleaning validation work (IQ, OQ, PQ, & DQ)
  • Performing validation master planning and leading validation strategic planning efforts
  • Developing and revising new or existing procedures to ensure compliance to cGMP, GLP, FDA and worldwide regulations.
  • Providing technical advice on new equipment and modification to existing equipment to ensure validation/qualification status is maintained in a state of control
  • Recommending improvements in policies and procedures, to enhance the ability to conform to and maintain compliance with site, corporate and regulatory standards.
  • Coordinating validation activities by constantly communicating with affected departments and personnel
  • Managing client relations
  • Directing and supporting junior level engineers

What you’ll like most about working with our Validation & Commissioning team at Pharmatech Associates:

  • Everyone at Pharmatech Associates contributes to the success of our projects, departments and company.  Your input will not only be heard; it will be encouraged and valued.
  • We are consultants, and you will move from project to project.  You will have endless opportunities to learn and for career growth.
  • Your coworkers are a group of highly intelligent and motivated employees.  There will always be someone in-house that has done the job you were hired to do, and you will be able to learn from them.
  • We take great pride in offering our employees the best benefits and competitive compensation packages in our industry, plus performance-based bonus incentives.
  • Fantastic co-workers and no internal politics!  A culture that thrives on true collaboration.

We’re looking for candidates who:

  • Earned a bachelor’s degree in engineering or life sciences
  • Have 7+ years’ experience in the regulated life sciences industry with 5 years of progressive experience in validation
  • Exhibit above-average proficiency with cGMPs, GDP & GEP
  • Thoroughly understand the validation life cycle and are experienced with IQ, OQ, PQ, DQ protocol generation and execution
  • Demonstrate a know-how of solid dosage process equipment, automation system, facility and utility qualifications and project management
  • Display exceptional communication (written and verbal) and interpersonal skills
  • Are motivated, with the ability to work in a team environment or effectively work independently at client sites
  • Can travel domestically and overnight to client project sites
  • Easily and efficiently use the suite of Microsoft Office products

Preferred qualifications:

  • Experience working for a consulting firm
  • Project Management Experience
  • Cleaning Validation experience
  • Computer Systems Validation Experience

About Pharmatech Associates:

At Pharmatech Associates, our mission is to fulfill customer expectations throughout the development and execution of tailored, high value, innovation solutions.  We are committed to fostering an environment that is professional and forth right.  These principles are captured in the values we believe are essential to maintaining our supportive culture and our commitment to our clients’ success.   We seek to establish an atmosphere of openness, objectivity, accountability, mutual respect and teamwork so each employee can realize their fullest potential for personal and professional growth. We value work life balance.  At Pharmatech talent matters, and we tackle each project with a “no fear” attitude.  We stand together as a team, and we’ve got your back.  Pharmatech’s commitment to integrity is unwavering.

 

EEOC Statement:

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.