PACT Pharma
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Sr. Quality Assurance Validation Engineer

Quality Assurance


PACT Pharma is an exciting, well-funded biotechnology company, advancing to clinical studies in 2019 with facilities and laboratories in South San Francisco, CA.  PACT Pharma is developing personalized adoptive T cell therapies for the eradication of solid tumors.  We are in the San Francisco bay area, in the heart of the world’s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. 

PACT Pharma is developing tumor-mutation-targeted T Cells tailored for each patient. Tumor mutation (neoE) targeting is programmed into the patient’s own T cells to seek out & kill the tumors. Using (non-viral) precision genome engineering, the neoE-targeted Tcell receptors (TCRs) replace the endogenous TCR of fresh CD8 and CD4 T cells collected from that same patient followed by minimal expansion in closed systems for re-infusion into the patient. These patient-specific neoTCR-P1 cells are formulated to immediately kill all neoantigen-expressing tumors, together with a deep reservoir of ‘ready-to-go’ neoTCR-P1 cells for long-term persistence and capable of rapid expansion to prevent future cancer recurrence. 

We are currently recruiting for Sr. Quality Assurance Engineer, reporting to the Director, Quality Assurance. This position will be based in South San Francisco

Responsibilities:

The ideal candidate is an experienced QA Engineer with a track record of success in GMP environments and understands biologics and/or cell therapy processes (i.e. cell culture, expansion, fill/finish, aseptic environments, reagent/media control, contamination control). The job incumbent will be responsible for the following in support of QA activities:

  • Provide QA oversight for qualification and validation lifecycle including but not limited to equipment, analytical instrument, process, and cleaning within cGMP environment.
  • Draft and revise standard operating procedures (SOPs), qualification & validation-related templates per PACT Pharma's Quality System requirement.
  • Review and approve qualification and validation documents including commissioning, Risk Assessment, Qualification and Validation protocols (IQ, OQ, PQ), summary reports, and all related documents as needed to support cGMP manufacturing and QC laboratory systems.
  • Resolve and approve qualification and validation discrepancies and deviations.
  • Lead Quality initiatives for new cGMP Aseptic product and raw material facility construction. 
  • Partner and drive implementation for cGMP new equipment management program. 
  • Implement periodic review process.
  • Review Change Control records, as needed.
  • Review equipment maintenance and calibration certificates.
  • Provide training and guidance on Quality Assurance topics to foster a quality culture and quality mindset.
  • Perform compliance review of internal controls and procedures in PACT Pharma’s Quality System and ensure alignment with current regulatory requirements.
  • Prepare Quality metrics to show the health of PACT’s Quality System and make recommendations/improvements in policies and procedures.
  • Other functions as necessary for QA under management’s discretion and in support of QA systems.

Minimal Qualifications:

  • Must have a thorough working knowledge of personal computer systems and desktop office applications, including Word, Excel, and PowerPoint. Excellent verbal and written communication skills.
  • Great knowledge of regulatory qualification and validation requirements
  • Ability to build strong working relationships with multiple departments.
  • The ideal candidate holds a bachelor’s degree or higher in relevant biological sciences.
  • The role demands a highly goal-driven approach and the ability to focus on time-sensitive objectives.
  • Must have worked for 5+ years in the industry with cGMP Quality Assurance experience in a similar environment. 

PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status. 

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