Engineer III, Validation
Core
Execute commissioning, qualification, and validation (CQV) for pharmaceutical manufacturing equipment, facilities, utilities, and automation systems to ensure GMP compliance.
Role type
Validation Engineer (CQV)
Builds
Validated manufacturing processes and compliant technical documentation for pharmaceutical/biotech production
Domain
Pharmaceutical manufacturing / Biotechnology / Highly regulated environments
Required skills
cGMP compliance, validation protocol development (IQ/OQ/PQ), risk assessment, root cause analysis, technical writing, cross-functional collaboration, engineering principles (via careerplan.io/jobs/R-01368268-engineer-iii-validation-at-thermofisher)
Preferred skills
aseptic processing, automated visual inspection (AVI), packaging, cold storage, Optima/IMA equipment, regulatory audit support, continuous improvement methodologies
Technologies
Microsoft Office, engineering/validation software tools
Responsibilities
Plan and execute CQV protocols for equipment and facilities; Verify validation activity completion and documentation accuracy; Support qualification of automation controls and computer systems; Develop risk assessments for validation strategy; Partner with cross-functional teams on validation activities; Investigate issues and support corrective actions; Maintain inspection-ready technical documentation
Seniority
Mid-Senior, hands-on IC