Process Validation Engineer

• High-visibility validation work at a major biotech site.
• Initial 6–7 month term with a strong likelihood of extension (not guaranteed, but the work pipeline points that way).

The Senior Process Validation Engineer will independently author and execute process validation deliverables across the validation lifecycle, partnering closely with Manufacturing Sciences (MSAT), Manufacturing, Quality, and Process Development. As a senior individual contributor, this person is expected to own deliverables with minimal oversight and drive cross-functional alignment. The role centers on Process Performance Qualification (PPQ) and Continued Process Verification (CPV) for commercial drug substance processes, with an emphasis on right-first-time documentation and on-time execution.

• →Author, execute, and report on PPQ protocols for drug substance manufacturing processes.
• →Support the full process validation lifecycle — Stage 1 (process design) through Stage 2 (PPQ) and Stage 3 (Continued Process Verification).
• →Develop and maintain control strategy elements, process monitoring plans, and CPV trending.
• →Perform statistical analysis of process data (capability, trending, limits) using Minitab or JMP.
• →Author and review validation deviations, investigations, CAPAs, and change controls within GMP quality systems.
• →Partner cross-functionally with MSAT/Manufacturing Sciences, Manufacturing, QA, and Process Development to align validation activities with production schedules.
• →Support process characterization and tech-transfer activities as needed.
• →Ensure all work complies with FDA process validation guidance, ICH Q8–Q12, and EU GMP (Annex 15).
• →Maintain accurate, audit-ready GMP documentation and validation records.

• BS in Chemical, Biochemical, or Biomedical Engineering, Biology, Biochemistry, or a related technical field.
• 8+ years of process validation experience in a pharmaceutical or biotech GMP manufacturing environment, at a senior/lead level. 
• Hands-on experience authoring and executing PPQ protocols and reports.
• Working knowledge of the process validation lifecycle and current FDA process validation guidance.
• Statistical analysis experience using Minitab or JMP.
• Strong GMP technical writing skills.
• Able to work onsite in the San Diego area and be fully productive from day one given the short engagement window.

• Large-scale biologics drug substance experience (mammalian cell culture and downstream purification).
• Prior experience at a large-scale commercial biologics manufacturer.
• Familiarity with relevant unit operations: bioreactors, chromatography, UF/DF, viral filtration.
• Experience with electronic batch records / MES and validation lifecycle management systems.
• Tech-transfer experience.

Because this is a focused, senior-level engagement, the ideal candidate is a career consultant or contractor who has owned PPQ campaigns end-to-end and can be fully productive almost immediately — there isn't runway for a long ramp. Prior large-scale biologics drug substance experience and recent contract history are strong positive signals. Local or relocation-ready candidates are preferred given the onsite requirement in the San Diego area.

Salary Range: $75 - $85 / hourly range is an estimate of pay for project-based employment. Range varies based on knowledge and experience. Higher rates possible for short-term assignments and independent contractors. If you are a dedicated Validation Engineer with a passion for ensuring the quality and compliance of manufacturing processes in the biopharmaceutical industry, we want to hear from you! Join us on our mission to revolutionize medicine and transform lives. Apply now to be part of a dynamic team driving innovation in California and beyond.