Validation Engineer
Katalyst CRO · Cambridge, MA · 1 mo ago
On-siteEngineeringContract
About the role
We are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing environments.
Responsibilities
- Develop and execute IQ/OQ/PQ protocols for both new and legacy manufacturing processes and equipment
- Perform Test Method Validation (TMV) and Computerized System Validation (CSV) in accordance with GAMP 5
- Develop and maintain Master Validation Plans
- Define CTQ-based acceptance criteria and establish traceability across risk controls, process parameters, and validation outputs
- Conduct PFMEA and change control impact assessments
- Author protocols, deviation reports, and validation summaries that hold up to regulatory scrutiny
- Drive validation workstreams independently across multiple concurrent projects
- Collaborate cross-functionally with Quality, Manufacturing Engineering, R&D, QC, Regulatory Affairs, and IT
Requirements
- 10+ years of experience in medical device or regulated manufacturing environments
- Strong hands-on expertise in IQ/OQ/PQ protocol development and execution for both new and legacy manufacturing processes and equipment
- Expertise in Test Method Validation (TMV) and Computerized System Validation (CSV) in accordance with GAMP 5
- Working knowledge of regulatory frameworks: ISO 13485, ISO 14971, EU IVDR 2017/746, and FDA 21 CFR 820
- Demonstrated ability to develop and maintain Master Validation Plans, define CTQ-based acceptance criteria, and establish traceability across risk controls, process parameters, and validation outputs
- Experience with PFMEA and change control impact assessments
- Proficiency in statistical methods used in validation, including Measurement System Analysis (MSA), process capability analysis, and sampling plan design
- Strong technical writing skills
Preferred qualifications
- Familiarity with CLSI guidelines and ISO 15189 for analytical/diagnostic method validation