Sr. Process Validation Engineer

Responsibilities

• Provide technical and strategic leadership for process validation of new and existing sterile injectable manufacturing processes, including formulation, compounding, filtration, aseptic filling, lyophilization, and terminal sterilization, as applicable
• Own and drive lifecycle process validation strategy, ensuring risk-based, scientifically justified approaches aligned with FDA/EMA guidance, ICH expectations, and internal quality standards
• Lead the development, review, and approval of key validation deliverables, including Process Validation Master Plans, risk assessments, protocols, control strategy elements, and final validation summary reports
• Set validation direction and standards for parameters, sampling strategies, acceptance criteria, and statistical approaches; ensure consistent application across products, programs, and manufacturing areas
• Serve as the primary validation interface with Manufacturing, Quality, Engineering, and external clients to ensure end-to-end process readiness for PPQ and commercial manufacturing
• Lead process validation planning and execution for technology transfers, including assessment of development history, identification of validation gaps, definition of validation scope, and readiness for PPQ execution
• Provide senior oversight and technical guidance for equipment, facility, and utility qualification activities, ensuring robust alignment with process validation requirements
• Provide expert validation impact assessments for changes related to process, equipment, raw materials, analytical methods, and facilities, supporting change control and regulatory commitments
• Establish and oversee continued process verification programs
• Act as on-the-floor validation lead during PPQ execution, process confirmation runs, technology transfer campaigns, and high-risk or high-visibility manufacturing operations
• Ensure validation documentation is inspection-ready, supporting internal audits, client audits, and global regulatory inspections
• Serve as a SME during regulatory inspections and client audits; lead inspection preparation, participate in interviews, and support responses to inspection observations
• Continuously improve validation practices, incorporating lessons learned, regulatory trends, and industry best practices to enhance efficiency, compliance, and product quality

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline
• 5–8+ years of experience in process validation, CQV, MS&T, or manufacturing support within a regulated pharmaceutical environment
• Strong understanding of sterile injectable manufacturing processes and aseptic processing principles
• Solid working knowledge of cGMP requirements and validation lifecycle concepts
• Demonstrated experience authoring and executing process validation protocols and reports

Preferred Qualifications

• Experience working in a CDMO environment and sterile injectable drug product manufacturing
• Familiarity with equipment and facility qualification and CSV validation
• Experience supporting regulatory inspections and client audits as a validation SME
• Knowledge of continued process verification, process capability analysis, and lifecycle management
• Experience working with electronic validation systems, MES, or electronic batch records

Physical / Safety Requirements

• Occasional overtime may be required, including evenings or weekends to support validation execution or manufacturing schedules
• Position requires extended periods of sitting with routine walking and standing in manufacturing areas
• Must be able to qualify for classified manufacturing area gowning as applicable
• Must be able to wear required personal protective equipment (PPE)