Position: Process Verification Engineer
Location: Pune, India
Experience: 5–7 Years
Industry: Medical Devices
Job Summary
We are looking for a Process Verification Engineer with hands-on experience in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) within the medical device industry. The candidate should possess strong validation documentation skills and experience supporting manufacturing process qualification in compliance with global regulatory standards.
Key Responsibilities
- Plan and execute IQ, OQ, and PQ activities for manufacturing processes and equipment.
- Prepare validation protocols and reports.
- Develop risk assessments and validation strategies.
- Perform process verification and process capability studies.
- Review manufacturing documentation and technical files.
- Collaborate with Manufacturing, Quality, R&D, and Regulatory teams.
- Support CAPA investigations related to validation activities.
- Ensure compliance with FDA and ISO 13485 requirements.
- Maintain complete validation documentation throughout the product lifecycle.
Required Skills
- 5–7 years of process validation experience.
- Strong expertise in:
- IQ
- OQ
- PQ
- Process Validation
- Equipment Qualification
- Technical Documentation
- Validation Protocol Development
- Experience in medical device manufacturing.
- Strong documentation and report-writing skills.
- Knowledge of statistical tools (Minitab preferred).
Preferred Qualifications
- Experience with FDA 21 CFR Part 820 and ISO 13485.
- Understanding of GHTF/IMDRF validation guidelines.
- Exposure to manufacturing engineering processes.
Pay: ₹60,000.00 - ₹70,000.00 per month
Work Location: In person
