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Cleanroom/packaging process specialist

Cirencester
Process specialist
Posted: 7h ago
Offer description

Corin Group is a global orthopaedics innovation business, which is head quartered in Cirencester, Gloucestershire! Across 7 units in Love Lane, we manufacture knee and hip implants that are then shipped around the world to provide patients the best possible outcomes! With over 400 employees, we are focused on precision, quality, and customer demand to ensure that we are producing a high quality product at all times. Due to the exciting growth of Corin, we are expanding our team and are looking for a Cleanroom/Packaging Process Specialist to support and optimise our Cleanroom and Packaging operations, ensuring high-quality, compliant production within a medical device environment. As the Cleanroom/Packaging Process Specialist, you will: Support the Cleanroom and Packaging teams to implement, control and continuously improve manufacturing processes. You’ll play a critical role in maintaining compliance while improving efficiency and product quality. Ensure cleanroom and packaging activities follow approved procedures and meet GMP, ISO 13485, FDA and MDR requirements Review and analyse manufacturing data to confirm work is completed in line with SOPs, protocols and regulations Create, review and maintain SOPs, work instructions and other technical documents Support change management by assessing process or product improvements and managing associated risks Provide technical support to production and investigate issues using root cause analysis Lead non conformance investigations, assess GMP impact and drive corrective and preventive actions (CAPAs) to completion Improve manufacturing processes to increase efficiency, quality and cost effectiveness Take part in Operational Excellence and Continuous Improvement activities Support the introduction of new equipment, processes and technologies into production Deliver assigned projects and always follow QMS and GMP requirements The ideal Cleanroom/Packaging Process Specialist will have/be: You will be an organised, methodical problem-solver with a strong technical and regulatory background, comfortable working in a fast-paced, environment. Experience within the medical device/pharmaceutical sector or a closely related regulated industry Strong understanding of cGMP legislation and Quality Systems Solid technical background with regulatory and quality awareness Excellent technical writing and documentation skills Strong communication skills with the ability to engage at all levels Proven ability to investigate issues through data analysis and stakeholder input Highly organised with strong attention to detail and planning ability Ability to manage multiple priorities under pressure Project management capability and strong presentation skills Computer literate The hours for this role are Monday - Friday 8:30 - 17:00 We offer great benefits which include; 25 days holiday plus bank holidays A free canteen where you are able to enjoy hot and cold meals! Excellent pension – starts at 6%, going up to 9.7% after 18 months. Life assurance – Six times your basic salary Private medical insurance with BUPA for you and your family Free annual eye tests and flu vaccinations Employee referral program where you can earn up to £1,000 for each successful hire you recommend

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