Process Validation Engineer

Job Title: Process Validation Engineer Location: Raynham, MA (On-site) Experience: 1–5 years Duration: 12+ Months Eligibility: US Citizen or Green Card holders only

Role Overview

This role supports manufacturing and quality operations through execution of process, equipment, and test method validations. The Validation Engineer will work closely with engineering, quality, and manufacturing teams to ensure compliant and efficient production processes in a regulated environment, with a strong preference for medical device manufacturing experience.

Key Responsibilities

Execute and support process and equipment validations including IQ, OQ, PQ, FAT, and SAT

Plan, author, and review validation protocols and reports

Perform Test Method Validations (TMVs) in accordance with regulatory and internal requirements

Support validation activities for new equipment, processes, and manufacturing changes

Develop and maintain manufacturing documentation including Work Instructions, Specifications, and Inspection Procedures

Conduct and document process risk assessments including pRAS, pFMEA, and FMCA

Collaborate cross-functionally with Manufacturing, Quality, Engineering, and Operations teams

Ensure validation activities comply with FDA and EU regulatory requirements

Support audits and inspections by providing validation documentation and technical input

Identify and implement continuous improvement opportunities within validation and manufacturing processes

Required Qualifications

Bachelor’s degree in Engineering or a related technical discipline

1–5 years of experience in a manufacturing environment

Hands-on experience with process and equipment validation activities

Exposure to CNC machining, metal casting, metal finishing, plastic or wax injection molding, and laser processing

Working knowledge of FDA and EU regulations applicable to medical device manufacturing

Experience generating and maintaining controlled manufacturing and validation documentation

Preferred Qualifications

• Medical device manufacturing experience

• Familiarity with risk management tools and methodologies

• Experience working in regulated environments with strong documentation practices

• Key Skills

• Process Validation

• Equipment Qualification

• Test Method Validation

• Manufacturing Documentation

• Risk Management

• Regulatory Compliance

• Cross-functional Collaboration

• Attention to Detail