Project Manager, Validation/CQV

Job ID: | Position Type: Contract

location

Carlsbad, CA

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.

Apply:  Please send your resume to careers@pai-qbd.com