Validation Engineer
Deeside | Full-Time On-Site | 6-Month Contract | Start ASAP
Umbrella: £60 per hour
The Opportunity
We are currently recruiting for a Validation Engineer to support a leading manufacturing operation within a highly regulated environment.
You will play a key role in ensuring that production processes and equipment are fully validated, compliant with regulatory standards, and delivered in line with project timelines.
Key Responsibilities
* Lead and execute process validation activities across multiple manufacturing systems
* Author and execute:
* OQ (Operational Qualification) protocols
* Engineering studies and validation reports
* Deliver process characterisation studies using statistical techniques
* Develop and maintain validation documentation, including Master Validation Plans
* Ensure compliance with relevant GMP, FDA, and ISO standards
* Support computer system validation (CSV) and 21 CFR Part 11 assessments
* Collaborate with engineering, quality, and manufacturing teams to drive compliance and continuous improvement
* Provide guidance and mentoring on validation processes and documentation
Skills & Experience Required
* Proven experience in validation engineering within a regulated environment (medical devices or pharmaceuticals)
* Strong understanding of:
* GMP and quality systems
* ISO 13485, FDA QSR, and regulatory compliance frameworks
* Experience with:
* Process validation and equipment qualification (IQ/OQ/PQ)
* Statistical tools (e.g. Minitab)
* Cleanroom environments (Class 7/8 desirable)
* Ability to write and execute technical validation documentation
* Strong stakeholder engagement and problem-solving skills
Qualifications
* Degree in Engineering, Science, or a related discipline (or equivalent experience)