Packaging Engineer

Reed Specialist Recruitment; Gloucester; Presencial; GBP 65 000 - 90 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Discretionary annual bonus

Private medical insurance

Life assurance

Resumo da oferta

Reed Specialist Recruitment is seeking a Senior Packaging Validation Engineer for a highly regulated medical devices manufacturer. You will own packaging and labeling validation across a global product portfolio and drive regulatory submissions.

The role involves leading testing, documentation reviews, CAPAs, audits, and mentoring junior staff while working cross-functionally with Quality, Regulatory, R&D and Manufacturing to ensure patient safety and compliance.

Qualificações

• Degree qualified in Engineering or a related technical discipline.
• Experience in Medical Devices, Pharmaceuticals or other highly regulated manufacturing environments.
• Strong knowledge of packaging and labelling validation principles.
• Experience with ISO 13485, ISO 11607, 21 CFR Part 820, MDR/MDD, ASTM, GMP.

Responsabilidades

• Lead packaging and labelling validation activities for medical devices.
• Manage transportation testing, shelf-life studies and equipment validation projects.
• Review and approve technical documentation, packaging specifications, BOMs and labelling content.
• Drive improvements to packaging and labelling systems, processes and validation strategies.
• Support new product introductions and system implementation projects.
• Work with Quality, Regulatory Affairs, R&D and Manufacturing to align on validation plans.
• Lead investigations related to non-conformances, CAPAs and customer complaints.
• Act as a key contact during audits and regulatory inspections.
• Deliver training and mentorship to junior team members.
• Support regulatory submissions and technical responses to external authorities.

Conhecimentos

Packaging validation

Labelling validation

Regulatory compliance

Project management

Analytical thinking

Stakeholder management

Excellent communication

Formação académica

Bachelor's degree in Engineering

Descrição da oferta de emprego

Are you an experienced Packaging, Validation or Quality Engineer looking to play a key role in the compliance and safety of highly regulated manufacturing products used across the globe?

We are seeking a Senior Packaging Validation Engineer to join a highly regarded manufacturer, taking ownership of packaging and labelling validation activities across a diverse global product portfolio. This is an excellent opportunity to work within a collaborative, quality-driven environment where your expertise will directly contribute to patient safety, regulatory compliance and continuous improvement.

What You'll Be Doing

• Lead packaging and labelling validation activities for medical devices.
• Manage transportation testing, shelf-life studies and equipment validation projects.
• Review and approve technical documentation, packaging specifications, BOMs and labelling content.
• Drive improvements to packaging and labelling systems, processes and validation strategies.
• Support new product introductions and system implementation projects.
• Work closely with teams across Quality, Regulatory Affairs, R&D and Manufacturing.
• Lead investigations relating to non-conformances, CAPAs and customer complaints.
• Act as a key contact during internal, customer and regulatory audits.
• Deliver technical training and provide mentorship to junior team members.
• Support regulatory submissions and technical responses to external authorities.

What We're Looking For

Essential

• Degree qualified in Engineering or a related technical discipline.
• Experience within Medical Devices, Pharmaceuticals or another highly regulated manufacturing environment.
• Strong knowledge of packaging and labelling validation principles.
• Experience working with:
• ISO 13485
• ISO 11607
• 21 CFR Part 820
• MDR and/or MDD
• ASTM standards
• Good understanding of GMP requirements.
• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder management abilities.
• Experience managing technical projects and multiple priorities simultaneously.

Desirable

• Previous team leadership, mentoring or supervisory experience.
• Packaging equipment validation and qualification experience.
• Experience leading validation projects within a manufacturing environment.
• Exposure to regulatory inspections and external audits.

What's On Offer

• 25 days holiday plus bank holidays
• Discretionary annual bonus
• Excellent pension scheme starting at 6%, rising to 9.7%
• Private medical insurance for you and your family
• Life assurance at 6x salary
• Annual eye tests and flu vaccinations
• Employee referral bonus scheme
• Ongoing training and career development
• Opportunity to work on innovative, regulated products that improve patient outcomes worldwide

If you have experience in packaging validation, labelling compliance, quality engineering or medical device manufacturing and are looking for your next career challenge, we'd love to hear from you