Manufacturing Validation Engineer

United Pharma; Massachusetts; On-site; USD 110,000 - 150,000; Full time

Job summary

United Pharma seeks an experienced Validation Engineer to lead and execute manufacturing equipment validation in a regulated environment. You will collaborate with cross-functional teams to draft, review, and release IQ/OQ/PQ documents, and ensure compliance with ISO 13485, GMP, and 21 CFR Part 820.

The role emphasizes metrology, calibration, MSA, and robust documentation practices. Responsibilities include coordinating validation activities from vendor selection to commissioning, releasing

Qualifications

• Bachelor's degree required in mechanical/manufacturing/biomedical engineering or related field.
• Minimum 6+ years in manufacturing and equipment validation in regulated environments.
• Strong knowledge of ISO 13485, GMP, and 21 CFR Part 820; familiarity with ISO 14971 risk management.
• 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 (MasterControl, ETQ, etc.).

Responsibilities

• Support validation activities for landing and commissioning new manufacturing equipment.
• Review and approve IQ, OQ, PQ, TMV or Software Validation deliverables.
• Draft and review validation documents.
• Prepare validation documents CAF, IQP, IQ report, OQP, OQ report, PV/PQ protocols and reports.
• Release documents in PLM Windchill and manage related documentation.
• Coordinate with vendors, EHS, Quality, Validation and cross-functional teams.
• Follow up approvers and ensure timely approvals.

Skills

6+ years in manufacturing andEquipment

IQ/OQ/PQ protocol development

Validation in regulated environments

ISO 13485 GMP knowledge

21 CFR Part 820 familiarity

Risk management (ISO 14971)

Metrology calibration accuracy

MSA / process capability studies

EQMS / document control experience

Cross-functional collaboration

Education

Bachelor’s degree in mechanical engineering

Tools

Windchill PLM

MasterControl

ETQ

Job description

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.

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.