Manufacturing Validation Engineer

Manufacturing Validation Engineer

Location: Raynham, MA

Job Description:

• 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: 2–5 years 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.