Manufacturing Validation Engineer

Title: Manufacturing Validation Engineer Location: Raynham, MAJD as below Experience in medical device manufacturing is required Experience in process validation planning, execution and reporting is required Strong technical writing skills related to process validation documentation as well as manufacturing process documentation (work instructions, standard operating procedures, etc.) is required Create and maintain validation documentation, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports. Collaborate with Manufacturing, Quality Assurance, Regulatory Affairs, and Equipment Engineering to qualify new machines and implement change controls. Design, execute, and document calibration, metrology, and gauge R&R activities; ensure traceability of measurement equipment. Analyze process data (statistical methods, capability studies like Cp/Cpk, Gage R&R) to demonstrate repeatability, accuracy, and process control. Generate, review, and approve validation reports; ensure closure of deviations, CAPAs, and non-conformances. Required Qualifications Education: Bachelor's degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or related discipline. Experience: 2-5years in manufacturing and equipment validation in a regulated environment (MedTech, pharma, or healthcare devices). Regulatory & Standards: Strong knowledge of ISO 13485, GMP, and 21 CFR Part 820; familiarity with risk management (ISO 14971) and validation concepts (IQ/OQ/PQ). Technical Skills: Proficiency in developing and executing IQ/OQ/PQ protocols. Experience with metrology, calibration, and measurement system analysis. Knowledge of CNC machines, CAM software, and basic CNC programming concepts. Statistical tools experience (Minitab, JMP, or similar) for process capability studies. Document control and eQMS systems experience (e.g., MasterControl, ETQ, etc.). Communication: Strong written and verbal communication; ability to write clear validation documentation and present findings to cross-functional teams.

Created: 2026-03-17