Packaging & Labelling Engineer

We are looking for an experienced Senior Packaging & Labelling Engineer to join our Validation & Sterility Assurance team based onsite in Cirencester. This is a pivotal role responsible for ensuring the compliance, performance, and continuous improvement of our medical device packaging, labelling, and packing systems across a global portfolio. As the subject matter expert for packaging and labelling validation, you will lead critical projects, support regulatory compliance activities, mentor a small team, and work closely with colleagues across Quality, Regulatory Affairs, R&D, Manufacturing, and external partners. This is an excellent opportunity for a driven engineer who enjoys technical problem-solving, project leadership, and influencing business-wide quality and compliance strategies within a highly regulated medical device environment.

• Monitor and validate all aspects of medical device packaging and labelling, including:
• Transportation testing
• Shelf-life studies
• Equipment performance validation
• Labelling control systems
• Label content compliance
• Support a global portfolio of medical devices, including orthopaedic implants, reusable instruments, and single-use devices.
• Review and approve technical documentation, labels, and packaging Bills of Materials (BOMs).
• Drive continuous improvement of packaging and labelling validation strategies.
• Manage validation and improvement projects, including:
• Equipment qualification and validation
• Product evaluations
• New system implementation
• Collaborate with cross-functional global teams, including Regulatory Affairs, R&D, Quality, Operations, contractors, and external laboratories.
• Ensure regulatory compliance deadlines are achieved and maintained and provide technical responses to regulatory authorities.
• Develop and deliver training to operational teams.
• Lead investigations relating to non-conformances, CAPAs, and customer complaints.
• Act as an auditee during internal, customer, and regulatory audits.
• Mentor, supervise, and develop a small team, including participation in recruitment activities.
  Degree in a scientific, engineering, or related technical discipline.
• Proven experience within the medical device industry or another highly regulated environment.
• Strong understanding of packaging and labelling validation requirements.
• Experience working with:
• ISO 13485
• ISO 11607
• 21 CFR 820.75
• MDR and/or MDD
• ASTM standards
• Knowledge of Good Manufacturing Practice (GMP).
• Strong analytical, investigative, and problem-solving skills.
• Excellent attention to detail.
• Ability to manage multiple priorities and complex technical projects.
• Strong written and verbal communication skills with the ability to influence stakeholders at all levels.

Desirable

• Previous experience mentoring, coaching, or supervising others.
• Experience leading validation projects within a medical device manufacturing environment.
• Exposure to regulatory inspections and external audits.
• Experience of packaging equipment validation and qualification.

Why Join Us?

• Play a key role in ensuring the safety and compliance of innovative medical devices used worldwide. With the opportunity to Lead impactful projects within a collaborative, cross-functional environment
• A competitive salary of £58,000 - £62,750 and a discretionary annual bonus
• 25 days holiday plus bank holidays
• 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 from £1,000 for each successful hire you recommend
• Opportunity to work on regulated, high-impact medical device products
• Ongoing professional development and career progression opportunities
• Be part of a business committed to quality, innovation, and improving patient outcomes.

#J-18808-Ljbffr