Senior Packaging Validation Engineer – Medical Devices

Reed Specialist Recruitment; Gloucester; On-site; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Discretionary annual bonus

Private medical insurance

Life assurance

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Packaging validation

Labelling validation

Regulatory compliance

Project management

Analytical thinking

Stakeholder management

Excellent communication

Education

Bachelor's degree in Engineering

Job description

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.