Senior Validation Engineer

Stryker India Private Limited; Gurugram District; Hybrid; INR 2,800,000 - 4,000,000; Full time

Job summary

Stryker India Private Limited is seeking a Senior Engineer Validation to lead and execute validation activities for manufacturing processes and equipment in a hybrid work environment. You will ensure compliance with GMP, ISO13485, and regulatory requirements while collaborating across R&D, Manufacturing, Quality, Regulatory, and Operations teams.

Role requires hands-on IQ/OQ/PQ execution, experience with PDP and Design Controls, and strong documentation skills; travel up to 20% is expected.

Qualifications

• Bachelor's degree in engineering or related technical discipline.
• 6+ years of experience in Validation/Manufacturing/Quality Engineering in regulated industries.
• Hands-on IQ/OQ/PQ protocol execution experience.
• Experience reviewing test requirements derived from product requirements and validation.
• Working knowledge of GMP, FDA 21 CFR Part 820, ISO 13485.

Responsibilities

• Support new product and process introductions per PDP, Design Controls, and Quality System requirements.
• Collaborate with R&D, Manufacturing Eng, Quality, Regulatory, and Operations to industrialize and transfer new products into manufacturing.
• Participate in 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 IQ, OQ, and PQ activities for manufacturing equipment, processes, tooling, fixtures, and production systems.
• Support Master Validation Planning and lifecycle management activities.
• Ensure validation activities comply with GMP, FDA, ISO 13485, and internal quality requirements.
• Travel Percentage: 20%
• Experience Level: Senior Level

Skills

Validation engineering

Quality engineering

Regulatory knowledge

Project management

Education

Engineering degree

Tools

Minitab

EOL Tester

Job description

Senior Engineer Validation 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.

Travel Percentage: 20%

Experience Level Senior Level