Process Validation Engineer

Join to apply for the Process Validation Engineer role at Stark Pharma

Job Title: Process Validation Engineer

Location: Raynham, MA (On-site)

Experience: 1–5 years

Duration: 12+ Auk?

Eligibility: US Citizen or Green Card holders only

Role Overview: This role supports manufacturing and quality operations through the 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 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

Seniority level: Mid‑Senior level

Employment type: Full‑time

Job function: Quality Assurance