Validation Engineer
Katalyst CRO · Cambridge, MA · 3 mo ago
On-siteEngineeringContract
Roles & Responsibilities
- Develop and execute IQ/OQ/PQ protocols for new and legacy manufacturing processes and equipment.
- Lead Test Method Validation (TMV) and Computerized System Validation (CSV) in compliance with GAMP 5, ISO 13485, ISO 14971, EU IVDR 2017/746, and FDA 21 CFR 820.
- Manage Master Validation Plans, define CTQ-based acceptance criteria, and ensure traceability across risk controls, process parameters, and validation outputs.
- Conduct PFMEA and perform change control impact assessments.
- Apply statistical methods such as Measurement System Analysis (MSA), process capability analysis, and sampling plan design.
- Write validation protocols, deviation reports, and summaries adhering to regulatory standards.
- Collaborate effectively with Quality, Manufacturing Engineering, Research and Development (R&D), Quality Control (QC), Regulatory Affairs, and Information Technology (IT).