Senior Process Validation Engineer

Responsibilities

• Provide technical and strategic leadership for process validation of sterile injectable manufacturing processes
• Own and drive lifecycle process validation strategy aligned with FDA/EMA and ICH guidance
• Lead development and approval of Process Validation Master Plans, risk assessments, and protocols
• Serve as the primary validation interface with Manufacturing, Quality, and external clients
• Lead process validation planning and execution for technology transfers
• Provide oversight for equipment, facility, and utility qualification activities
• Establish and oversee continued process verification programs
• Act as on-the-floor validation lead during PPQ execution and manufacturing operations
• Serve as a Subject Matter Expert (SME) during regulatory inspections and client audits

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

About the Company

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization (CDMO) partnering with pharmaceutical and biotech companies to bring sterile injectable products to market.