Convatec has announced a major milestone in our R&D journey and commitment to our vision of pioneering trusted medical solutions to improve the lives we touch. We have unveiled plans to relocate the majority of our UK-based research and development (R&D) activities from Deeside to Manchester from 2027, alongside a significant expansion of our facilities in Boston. The new, planned Manchester facility has the potential to be a major R&D hub in our global network which will initially function as the company’s global testing laboratories, with cutting-edge analytical R&D capabilities including quality control and materials, regulatory functions, and health innovation, positioning Convatec at the forefront of medical technology development. Our new state-of-the-art facilities will also strengthen our collaboration with Manchester’s vibrant life sciences ecosystem, which includes leading universities, hospitals, and research institutions. About the role: The Senior Equipment Specialist will be responsible for the completion of all validation and compliance activities relating to the purchase of new and updating of existing equipment/software located within the Laboratories at Convatec Global Development Centre (GDC). The Senior Equipment Specialist should be detail-oriented, able to work on multiple projects and adapt to changes, with good problem-solving skills and strong communication are essential. Key Responsibilities: • Provide Subject Matter Expertise for laboratory equipment calibration and validation systems to ensure compliance with ISO13485, FDA 21CFR Part 820, and cGMP. • Participate in Equipment/Software Validation activities (e.g., FAT, SAT, IQ/OQ/PQ) ensuring adherence to industry best practices. • Complete validation documentation following cGMP and good documentation practices. • Coordinate with external vendors for H&S documentation and validation documents. • Analyze data and prepare technical reports as needed. • Participate in equipment related laboratory investigations to support Non-Conformances, CAPA’s, Change Control etc. • Evaluate and update SOPs to maintain equipment and calibrations. • Review and approve in house and external calibrations of laboratory equipment • Support software validation activities for laboratory systems, ensuring Data Integrity compliance and implementing remedial action plans. • Support implementation and maintenance of laboratory informatics software/platforms and lab enterprise systems (e.g., Maximo, LIMS, ELN). About You: • Thorough knowledge of quality and regulatory requirements (ISO13485, cGMP) in Medical Device/Pharmaceutical industries. • Previous experience with LIMS is preferable. • Possess strong technical and problem-solving skills. • Expertise in laboratory equipment/software validation, calibration, and maintenance, including 21 CFR Part 11. • Previous experience with the use of electronic data management systems. • Proficiency in technical documentation. • Effective communicator who can influence decisions and work independently or within teams. • Ability to collaborate with a wide scope of contacts at different levels of seniority. • Highly organized with excellent time management and attention to detail. • Flexible and responsive to changing priorities and ad-hoc requests. • Continuously updates technical knowledge and implements new processes. Qualifications/Education: • Degree in relevant science or engineering field, plus 5 years experience in laboratory equipment validation/calibration in Medical Device/Pharmaceutical Industry. • Experience with software validations, 21 CFR Part 11, and calibration management systems. • Proficiency in Microsoft Office and database applications. Working Conditions: • Hybrid working role based in Deeside in 2026, moving to Manchester in 2027 • Combination of laboratory and office environments. • Exposure to chemicals, reagents, and biological agents within laboratory areas. • Option for up to 2 days of remote work per week after role establishment, with minimal travel (5-10 days annually).