Senior Validation Engineer – GMP & QA Compliance

Jabil Malaysia; Bray; On-site; EUR 45,000 - 65,000; Full time

Job summary

Jabil Bray is seeking an experienced Validation Engineer to join our Engineering Team. You will develop and implement validation policies, review protocol data, and lead change control for critical equipment and systems.

Responsibilities include creating protocols (FAT, IQ, OQ, PQ), reviewing documentation, coordinating validation strategies, and maintaining master validation plans and procedures. The role requires regulatory knowledge (ISO 13485, 21 CFR), a quality-first mindset, and the

Qualifications

• BS in Engineering or equivalent.
• 1–3 years of validation or qualification experience in healthcare or other regulated fields.
• Experience in software validation is preferred.
• Hands-on experience with automation systems and tools used in equipment or process validation.
• Working knowledge of ISO 13485:2016 or equivalent.
• Knowledge of 21 CFR 820, or 21 CFR 210, 211 and Part 11 is a plus.

Responsibilities

• Develops validation and qualification protocols and tracks execution to meet project timelines.
• Develops and executes validations through FAT, IQ, SAT, OQ & PQ.
• Reviews and approves validation documentation to ensure site requirements are met.
• Coordinates and manages validation strategy for equipment and processes.
• Maintains and administers the change control program for critical equipment and systems.
• Drives continual improvement of validation programs and system-level documents.

Skills

Validation experience

Software validation

Automation systems

Regulatory knowledge

Quality systems

Education

BS in Engineering

Tools

Automation tools

Job description

Jabil Bray is seeking an experienced Validation Engineer to join our Engineering Team. You will develop and implement validation policies, review protocol data, and lead change control for critical equipment and systems.

Responsibilities include creating protocols (FAT, IQ, OQ, PQ), reviewing documentation, coordinating validation strategies, and maintaining master validation plans and procedures. The role requires regulatory knowledge (ISO 13485, 21 CFR), a quality-first mindset, and the