Validation Engineer

Bright Prospect; Bayan Lepas; On-site; MYR 45,000 - 65,000; Full time

Job summary

A leading medical device company in Bayan Lepas, Penang, is seeking a Validation Engineer. This role involves ensuring compliance with validation protocols and quality standards, developing Master Validation Plans, and collaborating with multidisciplinary teams. The ideal candidate will hold a Bachelor’s degree in Engineering and have at least 1 year of experience in a regulated environment. Strong knowledge of FDA and ISO requirements is essential for success in this dynamic role.

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.

Responsibilities

• Ensure validation protocols comply with quality standards and regulations.
• Develop and maintain Master Validation Plans.
• Collaborate with cross-functional teams to execute product qualifications.

Skills

Validation protocols

Quality assurance

Technical writing

Statistical analysis

Education

Bachelor’s degree in Engineering

Tools

FMEA

PFMEA

Job description

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 requirements.
• Familiarity with statistical analysis and risk‑management tools (FMEA, PFMEA).
• Excellent documentation and technical writing skills.

For those who have what it takes, please send in resume to:

Recruitment Consultant : Lara

Email : ****@brightprsopect.com.my