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 solid 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.
Robust expertise in:
IQ
OQ
PQ
Process Validation
Equipment Qualification
Technical Documentation
Validation Protocol Development
Experience in medical device manufacturing.
Solid 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
📌 Process Verification Engineer Pune
🏢 BN Associates
📍 Pune
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