Validation Engineer
1 day ago
Deeside
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)