Senior Engineer Validation

Stryker; Gurugram District; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Stryker is seeking a Validation Engineer in India to help industrialize and transfer new products into manufacturing. You will collaborate with R&D, Manufacturing Eng, Quality, Regulatory, and Operations to ensure robust validation and process transfer.

The role involves leading IQ/OQ/PQ activities, developing validation documentation, and ensuring compliance with GMP, FDA QSR, ISO 13485, and ISO 60601. Excellent problem solving and cross-functional teamwork are essential.

Qualifications

• Bachelor's degree in Mechanical/ Electrical/ Industrial/ Manufacturing engineering or related technical discipline.
• Minimum 6+ years of experience in validation, manufacturing, quality, or related discipline in regulated environments.
• Hands-on IQ/OQ/PQ protocols for equipment, processes, tooling, and systems.
• Experience reviewing test requirements from product requirements and EOL testing.
• Known with CSV methodologies and regulatory expectations.
• Strong GMP, FDA 21 CFR Part 820, ISO 13485, ISO 60601 knowledge and risk management.

Responsibilities

• Support new product and process introductions per PDP, Design Controls, and Quality System.
• Collaborate with R&D, Manufacturing Eng, Quality, Regulatory, and Operations to transfer products to manufacturing.
• Participate in manufacturing readiness activities: pilot builds, process characterization, verification, and ramp up.
• Develop, execute, and maintain validation documentation: Validation Plans, Risk Assessments, Protocols, Traceability Matrices, Final Reports.
• Lead and execute IQ, OQ, and PQ activities for equipment, processes, tooling, fixtures, and production systems.
• Support Master Validation Planning and lifecycle management.
• Ensure validation activities comply with GMP, FDA QSR, ISO 13485, ISO 60601, and internal requirements.

Skills

Validation Engineering

Manufacturing Engineering

Quality Engineering

CSV methodologies

GMP knowledge

ISO 13485

Education

Bachelor's degree in engineering

Job description

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.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.