Senior EOL Validation Engineer - IQ/OQ/PQ Expert (GMP/FDA)

Stryker Group; Hinoba-an; On-site; PHP 900,000 - 1,300,000; Full time

Job summary

Stryker Group in the Philippines is seeking a seasoned Validation Engineer to support IQ, OQ, and PQ activities and to help transfer new products into manufacturing.

You will collaborate with R&D, Manufacturing Engineering, Quality, Regulatory, and Operations to ensure GMP and FDA/ISO compliance, lead validation documentation, and assure a smooth production ramp with robust risk management.

Qualifications

• Bachelor's degree in a related technical discipline.
• 6+ years in Validation/Manufacturing/Quality Engineering in regulated industries.
• Hands-on IQ/OQ/PQ protocol execution.
• Experience reviewing test requirements from product requirements and EOL testers.
• Familiarity with CSV methodologies and regulatory expectations.
• Strong GMP/FDA ISO knowledge and risk management principles.

Responsibilities

• Support new product and process introductions per PDP, Design Controls, and Quality System requirements.
• Collaborate with R&D, Manufacturing Engineering, Quality, Regulatory, and Operations to industrialize and transfer new products into manufacturing.
• Lead manufacturing readiness activities including pilot builds, process characterization, verification, and production ramp up; understand verification vs. validation.
• Develop, execute, and maintain validation documentation (Validation Plans, Protocols, Risk Assessments, Traceability Matrices, Final Reports).
• Lead IQ/OQ/PQ activities for equipment, processes, tooling, fixtures, and production systems; ensure lifecycle management and Master Validation Planning.
• Ensure validation activities comply with GMP, FDA QSR (21 CFR Part 820), ISO 13485, ISO 60601, and internal requirements.

Skills

IQ/OQ/PQ execution

CSV knowledge

GMP/regulatory awareness

Documentation skills

Cross-functional collaboration

Risk management

Education

Bachelor's degree in Mechanical, Electrical, Electronics, Industrial or Manufacturing Engineering

Tools

MSA

Gage R&R

Process capability

Minitab

PFMEA

Job description

Stryker Group in the Philippines is seeking a seasoned Validation Engineer to support IQ, OQ, and PQ activities and to help transfer new products into manufacturing.

You will collaborate with R&D, Manufacturing Engineering, Quality, Regulatory, and Operations to ensure GMP and FDA/ISO compliance, lead validation documentation, and assure a smooth production ramp with robust risk management.