Overview
Senior Engineer Validation supporting new product and process introductions for regulated manufacturing. You will lead validation activities (IQ/OQ/PQ) and maintain validation documentation to ensure compliance with quality and regulatory requirements.
What you'll do
- Support product/process introductions aligned to PDP, Design Controls, and Quality System requirements.
- Collaborate with R&D, Manufacturing Engineering, Quality, Regulatory, and Operations to transfer products into manufacturing.
- Run manufacturing readiness activities including pilot builds, process characterization, verification, and production ramp up.
- Develop, execute, and maintain validation documentation (Validation Plans, Risk Assessments, Protocols, Traceability Matrices, Final Reports).
- Lead and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment/processes and production systems.
- Support validation lifecycle activities including Master Validation Planning.
- Ensure validation activities comply with GMP, FDA, ISO 13485, and internal quality requirements.
What you'll need
- Bachelor’s degree in Mechanical, Electrical, Electronics, Industrial, Manufacturing Engineering, or a related discipline.
- Minimum 6+ years of experience in Validation Engineering, Manufacturing Engineering, Quality Engineering, or related roles in regulated industries.
- Hands-on experience executing IQ/OQ/PQ protocols for equipment, processes, tooling, fixtures, and manufacturing systems.
- Working knowledge of Computer System Validation (CSV) methodologies and regulatory expectations.
- Strong understanding of GMP, FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 60601, and risk management principles.
Nice to have
- Experience with PFMEA, Control Plans, PPAP, and process qualification methodologies.
- Working knowledge of MSA, Gage R&R, process capability analysis, and statistical tools such as Minitab.
- Experience supporting New Product Development (NPD), design transfer, and manufacturing scale-up activities.
Details
- Work flexibility: Hybrid.
- Travel percentage: 20%.
- Location: Gurugram, India.
Read the full description and apply on the company’s own careers page.
