Quality Specialist Engineer

Job description

This is a full time, minimum 9 month Maternity Cover position. Normal hours of work 39 hours per week. This is generally 8 hours Monday to Thursday and 7 hours on a Friday. Flexi time set up whereby if time has been built up during the week it can be used on a Friday afternoon once the core hours have been worked. Core hours are 10:00-15:00 Monday - Thursday and 10:00-14:00 on a Friday. As a Quality Specialist Engineer you will support GMP operations by providing expert oversight and guidance on investigations, change controls, and compliance activities, ensuring adherence to regulatory standards and fostering continuous improvement within the maintenance and engineering functions. Job Responsibilities that you be covering: You will provide oversight and expert guidance for investigations linked to Maintenance and Engineering activities, ensuring Change Controls are administered effectively and that all associated processes meet GMP expectations. You will ensure strict adherence to GMP standards across all Maintenance and Engineering operations within assigned areas, consistently reviewing compliance, documentation and operational conduct to maintain audit‑ready performance. You will review and assess change‑control documentation, deviations and failure‑investigation reports, identifying significant non‑conformances, escalating them appropriately and supporting timely, compliant resolution. You will review key GMP documentation — including standard operating procedures — maintain accurate records of investigations, deviations and change controls, and support the implementation of corrective and preventive actions. You will coach and support Maintenance and Engineering personnel in the execution of investigations, Change Controls and GMP‑compliance activities, delivering clear communication and targeted training where required. You will collaborate with cross‑functional teams to drive continuous improvement, monitor regulatory expectations and industry best practice, and perform daily operational activities in full alignment with site safety policies and procedures. What skills, qualifications and experiences you will hold as an Quality Specialist Engineer: You will hold a BSc in Biotech, Chemistry, Engineering or a related scientific discipline, supported by industry experience that enables effective contribution within a regulated environment. You will bring relevant hands‑on experience and will demonstrate a strong customer‑centric approach, consistently meeting the expectations of both internal and external stakeholders while ensuring processes are designed with the customer in mind. You will actively gather and apply customer feedback to improve services and outputs, understanding critical concerns and demonstrating that resolving customer issues is always a top priority. You will work to achieve business goals set by management, maintaining high standards of excellence, overcoming obstacles to meet targets, and applying the theories and practices required for success within your role. You will understand and clearly describe operational processes, demonstrating awareness of how other departments interact with your function, while maintaining professional behaviour, confidentiality and strong working relationships with colleagues and customers. You will uphold a strong commitment to safety, participating in safety meetings, identifying hazards, maintaining a clean and organised work environment and ensuring that all deliverables and commitments are completed accurately and on time.