Job Description Biocomposites is an international medical devices company that engineers, manufactures, and markets world leading products for use in infection management in bone and soft tissue. Based in Keele, UK, it has global operations across Europe, USA, Argentina, Canada, China, and India. Biocomposites is a world leader in the development of innovative calcium compounds and bone cements for surgical use. Its products regenerate bone and target infection risks across a variety of specialties, including musculoskeletal infection, orthopaedics, trauma, spine, foot and ankle, podiatry, and sports injuries. Biocomposites products are now used in over one million procedures per annum and sold in more than 100 countries around the world. The role The CQV Engineer (Commissioning, Qualification, and Validation) will primarily be accountable for the qualification and validation for Processes, Facilities, Equipment, and Computer System Validations in a Medical Device (cGMP) environment. Responsibilities The core duties will focus on hands-on CQV activities and compliance: Validation Activities: Organise and perform validation activities to provide an effective validation service. Compliance Documentation: Ensure all required documentation for a validation exercise, including validation protocols and summary reports, are created and maintained. SOP and Documentation Support: Provide input and technical expertise for the creation and revision of relevant Standard Operating Procedures (SOPs) and other quality \ Validation documentation. Project Alignment: Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans, objectives and schedules. Compliance Assurance: Ensure design projects relating to processes, facilities, equipment, and Computer System Validation are in compliance with regulatory and company requirements. Expert Advice: Provide validation support and advice to operations and other areas of the business as required to ensure that all operations are carried out in compliance with regulatory and company requirements. Specialist Knowledge: Provide specialist knowledge on validation of; process, facility, equipment and application of computer systems used within production and service. Continuous Improvement: Support a continuous improvement culture within the business. Essential Requirements Level 6 within a science regulated industry or relevant experience. Minimum 3 years Validation experience within Pharmaceutical/Medical Devices, including cleaning, analytical methods, lab equipment, and computer system validation and re-qualification. Creation of validation protocols and reports. Knowledge of Quality Management Systems. Comprehensive knowledge and experience with the following industry regulations and guidance: FDA 21 CFR Part 820 (Quality System Regulation for Medical Devices), ISO 13485:2016 (Medical devices - Quality management systems), ALCOA principles for Data Integrity (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available), ICH Q9 (Quality Risk Management) and its application to validation/qualification. Excellent communication skills Ability to meet deadlines Attention to detail Demonstrate positive and enthusiastic attitude Desirable Requirements Manufacturing process validation experience preferable, including validation of new processes and changes to established processes using the lifecycle approach to validation Proficient in Kneat or other alternative system and software packages People management skills Full, clean driving licence Occasional overtime requirements What do we offer? Competitive salary and benefits! With us, you will receive a competitive salary package and benefits. We grow talent. At Biocomposites we create opportunities to thrive and grow. One Biocomposites – team spirit & engagement. Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions. Who do we look for? People who are passionate about what we do. People who are open minded to evolving the way we work. People who can work together to transform outcomes and change lives. Benefits: Company events Company pension Employee discount Free or subsidised travel Free On-site parking