Validation Engineer

Location: Bayan Lepas, Penang

Job Responsibilities

• Ensure validation protocols (IQ, OQ, PQ) comply with quality standards as well as FDA 21 CFR Part 820 and ISO 13485 regulations.
• Develop, update, and maintain Master Validation Plans and associated reports.
• Evaluate validation data to verify it aligns with required specifications.
• Work closely with cross‑functional teams (Quality, Engineering, Manufacturing) to execute product performance qualifications.
• Assist with projects and process changes by reviewing and determining validation requirements.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Science, Biomedical, or related field).
• At least 1 year of experience in validation within a regulated industry (medical devices preferred).
• Strong understanding of IQ/OQ/PQ and validation lifecycle.
• Knowledge of cGMP, FDA, ISO 13485, and EU MDR...