Process Validation Engineer (Fill Finish)

Discover Your Role
- Supports technology transfer, process control strategy, validation, and post-commercialization activities
- Evaluates product and process risks throughout the process lifecycle
- Analyzes data from development, characterization, and at-scale manufacturing
- Collaborates with Manufacturing, QC, QA, and CMC Regulatory to support process lifecycle management
- Authors protocols, reports, and technical documents based on process and product knowledge
- Ensures SOPs, policies, and validation plans align with industry and regulatory standards (e.g., ICH guidelines)
- Supports audits, inspections, and CMC regulatory submissions
- Applies engineering principles to develop and execute process controls and validation strategies
- Uses statistical and engineering methods to assess manufacturing process performance
- Supports laboratory and manufacturing-scale studies

This Role Requires
- BS/BA in Engineering, Chemical Engineering, Biomedical Engineering preferred
- Process Controls & Validation Engineer: 2+ years of relevant experience
- Sr. Process Controls & Validation Engineer: 5+ years of relevant experience
- Level determined based on qualifications relevant to the role
- Preferred background in aseptic processing/fill finish, technology transfer, drug product process development, or biopharmaceutical process validation

Location/Work model
- East Greenbush, New York, United States
- Monday–Friday, 8am–4:30pm

Application
- Apply now.