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.

 

 

Vice President, Product and Process Development

The ideal candidate is currently a director or senior director working for a professional service organization in the regulated life science industry who is looking for a career advancement opportunity. 

 

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: 

  • As the subject matter leader, this individual will be responsible for identifying, developing, and differentiating Pharmatech’s key service offerings. These core elements will drive the success of the Products and Process Development business unit and may apply to any regulated life science product
  • The Vice President (VP) of Products and Process Development (PPD) is responsible for annual sales growth and market penetration of Pharmatech’s PPD services within the global regulated life sciences markets.
  • The VP of Products and Process Development will have primary responsibility for all client and project relationships within the PPD sphere. Displaying a high level of technical expertise, the VP of PPD will work to foster a high level of trust in accordance with Pharmatech’s branding
  • Within a short lead time and as required, assume leadership responsibilities anywhere across a client’s organization, from Project Relationship Manager to Project Leader to Project Subject Matter Expert.
  • Grow Pharmatech’s brand as a thought leader in the field of product and process development and as such publish articles and white papers on current global product development requirements, solutions and considerations. Participate in webinars and present at conferences periodically to reinforce Pharmatech brand, expertise and value.
  • Obtain and develop human capital within the Products and Process Development sphere with the goal of developing an organization with the capabilities to sustain Pharmatech’s growth and presence in the global compliance marketplace.

Qualifications:

  • Minimum Bachelor’s degree with a scientific or engineering related major, Master’s degree preferred.
  • At least 5 years of direct client management experience in a professional services organization and 10 years’ experience in a manufacturing environment for FDA regulated products.
  • Established subject matter expert with a strong national reputation in one or more core elements of the drug development lifecycle
  • Experience in performing a wide range of formulation, process development and validation of multiple pharmaceutical/biological dosage forms
  • Strong CMC understanding and process design experience and understanding for early and late stage products, with several examples of providing technical content to support successful regulatory filings
  • Current and proficient in newly introduced global concepts, practices, and procedures within the regulated life sciences industry
  • Essential knowledge of QRM, QbD and QMS frameworks, along with strong practical knowledge of ICH, FDA and EMA expectations and requirements
  • Possess a high level of business acumen with demonstrated successful financial management skills
  • Outstanding communication skills and dynamic interpersonal skills with the ability to work in a team environment and capable of communicating effectively at all organizational levels up to BOD
  • Thrives in a fast pace, demanding environment

 

Essential Job Functions:

Travel globally without restriction up to 20% and accommodate possible reoccurring, short-term, overnight stays.   Successfully pass background check and random drug screens.  Sit and stand for long periods of time and lift a minimum of 30 pounds.  Clearly articulate in English.  Comfortable working in confined spaces and interacting face to face with co-workers, client personnel and large groups.  Ability to work weekends and more than 8 hours per day as needed.

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.

 

 

 

Job site is in St. Louis, MO. Local candidates preferred, but qualified candidates from other areas will be considered.  Travel to the St. Louis client site will be from January through September 2020.  Project includes travel to Germany.

Senior Validation Engineer

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.

Duties:

  • As part of Pharmatech’s consulting teams, provide validation services to clients in the regulated life sciences industry: pharmaceutical, biotech and medical device companies
  • Perform a complete qualification of validation life cycle set of documents for an aseptic, automated assembly system
  • Independently review system requirements to perform the following tasking:
  • Review FAT and lead FAT execution in Germany in Spring 2020
  • Resolve FAT testing issues to ensure acceptance of system to be shipped to USA
  • Develop SAT protocol and prepare for execution in June 2020
  • Lead SAT protocol execution resolve testing discrepancies, and route for approval
  • Coordinate all validation activities by constant communication with affected departments and personnel
  • Prepare IOPQ protocol and execute in timely fashion (current schedule calls for IOPQ execution

completion in August 2020.

  • Final Performance Verification testing to be completed in September 2020
  • Prepare final validation report, trace matrix

Qualifications:

  • B.S. with a scientific or engineering related major is required
  • 5-15 years of validation work experience with demonstrated know-how of aseptic process equipment, automation system, facility and utility qualifications and project management
  • Candidate must be able to work independently and possess stellar communication and coordination skills and prepare and execute timing dependent tasking.
  • Candidate must be expert at developing and completing qualification of life cycle documents (URS, FAT, SAT, IOPQ, RTM) for aseptic automated systems. Familiarity with aseptic processing and validation of aseptic systems is required.
  • Candidate is preferred to have diverse validation background to lend support to additional validation tasking at site.
  • Must be able to work with minimal supervision in a fast-paced, annual shutdown environment
  • Manage client relations
  • Knowledge of Risk Assessment
  • Proven ability to mentor and oversee junior validation engineers
  • Experienced proficiency with GDP, GEP, GXP and cGMPS
  • Outstanding communication (written and verbal) and interpersonal skills with the ability to work in a team environment is a must
  • Excellent technical writing skill is critical
  • Must be exceptionally motivation, able to work independently and function in a team environment
  • Advanced computer skills and knowledge of Microsoft Office products required
  • Willingness to work at various client sites both in and out of California with possible extended travel

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.