Senior Packaging and Labelling Engineer

Senior Packaging & Labelling Engineer

Shape the Future of Medical Device Compliance

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.

What You'll Be Doing

As Senior Packaging & Labelling Engineer, you will:

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.

What We're Looking For

Essential

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.

Apply Today

If you're an experienced packaging and labelling professional looking to take the next step in your career and make a tangible impact within the medical device industry, we'd love to hear from you.

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