Product Process Validation Manager
About The Position
The is an exciting opportunity as Product Process Validation Manager is a key member of the Manufacturing Science & Technology (MS&T) organization, responsible for leading process validation strategy and execution across the product lifecycle. This role oversees the design, authorship, and facilitation of technology transfer activities, Process Performance Qualification (PPQ) protocols and reports, and supporting ongoing Continued Process Verification (CPV). The manager partners closely with Process Development, Quality, Manufacturing, and Regulatory Affairs to ensure robust, compliant, and efficient validation programs. This position reports directly to the Director of MS&T.
Requirements
- Bachelor’s or Master’s degree in Engineering, Life Sciences, Biotechnology, or related field.
- 7+ years of experience in biopharmaceutical or pharmaceutical manufacturing, MS&T, process validation, or related technical functions.
- Demonstrated expertise in PPQ, CPV, and technology transfer.
- Strong understanding of cGMP regulations and global validation guidelines.
- Excellent technical writing, communication, and project management skills.
Nice To Haves
- Experience with biologics, cell therapy, gene therapy, or aseptic manufacturing.
- Familiarity with statistical tools (e.g., JMP, Minitab) for process analysis.
- Prior leadership or team management experience.
- Experience supporting regulatory inspections.
Responsibilities
- Lead the development, authorship, and execution of process validation strategies in alignment with regulatory expectations (e.g., FDA, EMA, ICH Q8–Q11).
- Write, review, and approve PPQ protocols, sampling plans, risk assessments, and final reports.
- Facilitate cross-functional PPQ readiness, including coordinating activities with Manufacturing, Quality Control, and Quality Assurance.
- Ensure validation deliverables meet internal standards and external regulatory requirements.
- Serve as the MS&T lead for technology transfer of new products, processes, or scale-up activities into manufacturing.
- Develop and maintain tech transfer plans, process descriptions, and knowledge transfer documentation.
- Drive process fit-gap assessments, risk analyses, and mitigation strategies.
- Support equipment and facility readiness, including URS development and process capability assessments.
- Partner with data analytics and quality teams to monitor process performance, identify trends, and drive data-based decision-making.
- Lead investigations and corrective actions related to process performance deviations or CPV signals.
- Collaborate with Process Development to translate laboratory-scale processes into robust, scalable manufacturing processes.
- Support Regulatory Affairs with process validation content for submissions, responses to regulatory queries, and inspections.
- Provide technical leadership during audits and regulatory inspections.
- Mentor and guide junior MS&T staff in validation and tech transfer best practices.
- Ensure all validation and tech transfer documentation is accurate, complete, and audit-ready.
- Maintain strong alignment with internal quality systems, change control, and document management processes.
- Champion continuous improvement initiatives to enhance validation efficiency and process robustness.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
