Scientist 2/Engineer 2, MSAT Upstream or Downstream

Responsibilities

• Support the team with process validation requirements across equipment, systems, and manufacturing processes
• Ensure regulatory compliance; assess change notifications related to process validation
• Contribute to process validation strategy and execute all aspects of validation, including: Process Performance Qualification (PPQ) runs, Continued Process Verification (CPV), and other validation studies, as needed
• Collaborate with Validation/CQV to support Performance Qualification (PQ) execution and at-scale assessments (e.g., worst-case soiling for cleaning validation, microbial hold, mixing validation)
• Support process sub-teams throughout Technology Transfer (TT) phases
• Facilitate generation of sampling plans for Process Validation Reports (PVRs) and investigations
• Write and review documentation (e.g., validation campaign summaries, PPQ protocols and reports, impact assessments) for internal and external audiences
• Contribute to developing and implementing training for manufacturing staff on process validation requirements
• Support troubleshooting, process impact assessments, Root Cause Analysis (RCA), and Corrective and Preventive Actions (CAPA) in response to critical deviations, as needed
• Support TT stage-gate reviews for manufacturing readiness (e.g., process characterization and validation, risk assessments and mitigation, robust supporting data for proposed changes)
• Support creation of master plans, viral segregation risk assessments, process risk assessments, contamination control strategy, and extractables/leachables assessments; contribute to relevant site procedures and policies
• Participate in continuous improvement initiatives with Manufacturing, Quality, Engineering, and Global teams (as applicable) to improve manufacturability, reliability, yield, and cost
• Collaborate with Manufacturing to support commercial and clinical campaigns, including on-floor support
• Perform other duties, as assigned

Minimum Qualifications

• Bachelor’s degree in Engineering, Life Science, or Chemical Engineering with 2 years of relevant industry experience; or
• Master’s degree in Engineering, Life Science, or Chemical Engineering with no previous experience

Preferred Qualifications

• Experience using Quality Systems (e.g., deviation management system, change control, CAPA, document management system)
• Experience using risk management and RCA tools
• Experience working in a Good Manufacturing Practices (GMP) environment
• Prior drug substance manufacturing experience, including process validation

Knowledge, Skills, and Abilities

• Knowledge of regulatory audits and inspections and requirements (e.g., FDA 21 CFR Part 11)
• Understanding of GMP, GLP, and GDP requirements
• Knowledge of validation principles and techniques (IQ, OQ, PQ)
• Strong problem-solving and project management skills
• Excellent communication and teamwork skills; ability to present information clearly and adapt style to different audiences
• Ability to provide constructive feedback to peers and leaders