Field Validation and Service Engineer β UK β Healthcare β Permanent
About the Company:
We are looking for an Engineer with experience in validation and equipment qualification who is open a primarily field-based role. Ideally, you will be based in the midlands giving you easy access to motorway links although other locations will be considered for the right candidate.
Responsibilitie s:
- Executing validation and revalidation activities for manufacturing processes and cleaning methods, and associated equipment in line with approved protocols.
- Supporting equipment, utility, and controlled-environment qualification activities for production, storage, and handling operations.
- Carrying out Installation Qualification (IQ) and Operational Qualification (OQ) activities, alongside routine equipment servicing and maintenance.
- Completing validation protocols, data sheets, sampling records, and supporting documentation accurately and in real time.
- Recording process observations, test results, and critical parameters against defined acceptance criteria, escalating anomalies promptly.
- Assisting with investigations into validation failures, out-of-limit results, deviations, and changes affecting validated processes or systems.
- Preparing validation documentation packs, checking equipment and materials readiness, and coordinating activities with Production, Laboratory, Engineering, and Quality teams.
- Contributing to periodic reviews, requalification planning, and the maintenance of the site validation schedule.
- Maintaining controlled records in accordance with Good Documentation Practice (GDP), data integrity requirements, and internal documentation standards.
- Identifying opportunities to improve validation processes, documentation flow, and operational compliance.
- Supporting the site in maintaining a validated, compliant, and inspection-ready state.
- Assisting with equipment servicing when needed.
Requirements:
- A qualification at NVQ, BTEC, HNC, A-level, or equivalent level in a scientific, engineering, manufacturing, or technical discipline.
- Experience in a regulated manufacturing, laboratory, pharmaceutical, chemical, hygiene, or clean production environment.
- Experience working to Standard Operating Procedures (SOPs) and completing accurate documentation within a controlled environment.
- Knowledge of process validation, cleaning validation, equipment qualification, and routine verification principles.
- An understanding of Good Manufacturing Practice (GMP), hygiene controls, and validation requirements.
- The ability to interpret approved protocols, work instructions, technical specifications, and acceptance criteria.
- Strong data recording and review skills, with the ability to complete validation and quality records accurately.
- An understanding of data integrity principles, including the importance of contemporaneous, legible, and traceable documentation.
- The ability to recognise non-standard results, identify potential issues, and escalation concerns promptly and appropriately.
- Confidence using standard digital tools for documentation, data entry, and report preparation.
- A full, clean UK driving licence and willingness to travel extensively across the UK and Europe, approximately 75% of the time.
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Field Validation Engineer employer: Kinetica
Join a leading healthcare company in North Yorkshire that values quality and innovation, offering a supportive work culture where your contributions directly impact patient safety. With opportunities for professional growth and development, you will be part of a dedicated team committed to continuous improvement in the medical device sector. Enjoy a collaborative environment that fosters communication and teamwork, making it an excellent place for those seeking meaningful and rewarding employment.