Validation specialist Danvers - MA - Massachusetts

Write clear TMV protocols and reports Interpret test methods specifications and engineering drawings Apply Gage RR (repeatability reproducibility) Ability to select appropriate measurement tools (e.g. verniercalipers micrometers etc.)

Roles & Responsibilities: We are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing environments. Candidates must have strong hands-on expertise in IQ/OQ/PQ protocol development and execution for both new and legacy manufacturing processes and equipment, as well as Test Method Validation (TMV) and Computerized System Validation (CSV) in accordance with GAMP 5. solid working knowledge of regulatory frameworks is essential - specif

Roles & Responsibilities: We are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing environments. Candidates must have strong hands-on expertise in IQ/OQ/PQ protocol development and execution for both new and legacy manufacturing processes and equipment, as well as Test Method Validation (TMV) and Computerized System Validation (CSV) in accordance with GAMP 5. solid working knowledge of regulatory frameworks is essential - specif

Summary: Supports testing and validation activities for medical devices, ensuring compliance with regulatory and quality standards. bility to interpret engineering drawings and specifications. Roles & Responsibilities: Develop Test Protocols aligned with design verification plans and regulatory requirements. Prepare test samples and fixtures for mechanical and functional testing. Execute tests and document results per Good Documentation Practices (GDP). Generate Test Reports for inclusion in the