- Location
- Haryana, Gurugram International Techpark, Block I Phase 1 Floors G, 3, 4, 5, India
- Workplace
- Hybrid
- Type
- Full-time
- Department
- Engineering
- Seniority
- Senior
- Experience
- 6+ years
- Education
- Bachelor
- Source
- Workday
Description
Work Flexibility: Hybrid
What you will do:
- Support new product and process introductions in accordance with Product Development Process (PDP), Design Controls, and Quality System requirements.
- Collaborate with R&D, Manufacturing Engineering, Quality, Regulatory, and Operations teams to industrialize and transfer new products into manufacturing.
- Participate in manufacturing readiness activities including pilot builds, process characterization, verification, and production ramp up . Should have strong understanding of the difference between verification and validation.
- Develop, execute, and maintain validation documentation including Validation Plans, Risk Assessments, Protocols, Traceability Matrices, and Final Reports.
- Lead and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment, processes, tooling, fixtures, and production systems.
- Support Master Validation Planning and validation lifecycle management activities.
- Ensure validation activities comply with GMP, FDA, ISO 13485, and internal quality requirements.
What you will need:
Required Qualifications:
- Bachelor's degree in Mechanical Engineering, Electrical Engineering, Electronics Engineering, Industrial Engineering, Manufacturing Engineering, or a related technical discipline.
- Minimum 6+ years of experience in Validation Engineering, Manufacturing Engineering, Quality Engineering, or a related discipline within medical devices, pharmaceuticals, biotechnology, or other regulated industries.
- Hands-on experience executing IQ/OQ/PQ protocols for equipment, processes, tooling, fixtures, and manufacturing systems.
- Experience with reviewing test requirements derived from product requirements Validation and End-of-Line (EOL) Tester qualification and validation.
- 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.
Preferred Qualification:
- 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.
- Strong problem-solving, project management, and technical documentation skills.
- Excellent communication skills and ability to collaborate effectively across multidisciplinary global teams.
Skills
GMPFDARisk ManagementProject Management