Senior Process Validation Engineer

Biological License Application (BLA) filing experience with the FDA/regulatory agencies

Key responsibilities:

• Develop and implement process validation, qualification, and CPV strategies.
• Generate, review, and approve validation protocols and reports.
• Design, schedule, execute, and evaluate qualification and validation studies.
• Lead validation investigations, impact assessments, and process control strategy development.
• Analyze process and product data to evaluate performance and identify improvements.
• Serve as a validation subject matter expert during audits and customer meetings.

Basic qualifications:

• FDA or regulatory-agency BLA filing experience.
• Commercial manufacturing experience.
• Experience managing validation activities.
• Seven-plus years of experience in a cGMP environment.
• Bachelor’s or master’s degree in biochemistry, chemistry, chemical engineering, microbiology, or related life science.
• Five-plus years of process validation, PPQ, and/or CPV experience.

Preferred qualifications:

• Ten-plus years of manufacturing, process validation, PPQ, and CPV experience.
• Hands-on experience with cell culture upstream or downstream purification operations.
• Ability to lead and influence teams without direct authority.
• Strong critical thinking and technical problem-solving skills.
• Familiarity with cGMP document control systems and procedures.
• Strong technical writing, communication, documentation, and organization skills.