Manufacturing Validation Engineer
E-Solutions
Title: Manufacturing Validation Engineer
Location: Raynham, MA JD as below
Location: Raynham, MA JD 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.
- 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.
Vacancy posted 4 days ago
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