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Process Validation Scientist
3 months ago
Process Validation Scientist
- Demonstrate specific upstream cell culture and downstream purification unit operations knowledge in support of bioprocessing of large molecule biologics
- Lead Process Validation (Stage 3) activities including:
- Process validation strategies
- Protocols/reports review/approval
- Timely generation of Chemistry Manufacturing and Controls (CMC) documentation
- Collaboration between Manufacturing Sciences and Technology (MS&T), Manufacturing Regulatory and Quality
- Provides statistical support for product monitoring using techniques including statistical process control, process capability analysis, non-linear and linear regression and significant tests.
- Process investigation PV impact assessment strategies
- Collaborate with global process validation team
- Communicate CPV trends to Quality Management and CMC teams.
- Present/defend process validation packages and strategies during audits and inspections.
- Review/approve technical reports and deliver presentations utilizing sound compliance reasoning and interpretation of the available data
Essential for the role:
- Bachelor’s Degree preferably in Science or Engineering. Master’s Degree or PhD preferred.
- At least ten (10) years of overall experience in Scientific / Biotech / Pharmaceutical field with at least five (5) years of experience in Process Validation.
- Comprehensive knowledge PPQ and CPV regulatory expectations.
- Fundamental understanding of upstream and downstream process units for biopharmaceutical products.
- Broad understanding of Chemistry Manufacturing and Controls (CMC) activities and responsibilities with respect to Process Validation/Process Performance Qualification
- Knowledge of GMP manufacturing principles and documentation
- Proficient in statistical tools and techniques commonly used in the Biotech industry.
- Ability to apply critical thinking to solve problems and work independently
- Strong interpersonal and communication skills.
