Manufacturing Validation Engineer

Title: Manufacturing Validation Engineer

Location: Raynham, MA - Onsite

Long Term Contract Role - 2+ years

JD:

The scope of work may involve the following activities:

1. Support the validation activities involved with landing and commissioning new manufacturing equipment

2. Review and Approve IQ, OQ, PQ, TMV or Software Validation deliverables.

3. Assist in developing validation strategies.

Activities to be performed:

All Validation activities with respect to Vendor Selection, Feasibility trials, Development Work, Vendor Testing, Equipment Installation, Commissioning, Mold Qualification, Software Validation, Process Validation, Stability in Client's Site.

• Interacting with Vendor, EHS, Quality, Validation and other various cross functional departments.

• Drafting and Review of validation documents.

• Preparation of validation documents CAF, IQP, IQ report, OQP, OQ report, PV / PQ protocols & reports, Engineering trials, etc.

• Creation/Updates of URS, SWS, TM, WI, WRAPS, JSA, pFMCA, CSOP, MCP etc.

• Execution of validation documents CAF, IQ, OQ, PV, PQ, Engineering Trials.

• Release in PLM Windchill

• Creation of CR / CN documents.

• Review the documents with onsite team member and cross functional departments.

• Follow up the approvers.

• Release the documents in PLM Windchill

Required Qualifications

• Education: Bachelor’s degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or related discipline.
• Experience: 6+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 foundry casting process.
• 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.