Senior Process Engineer

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