Posted 6 days ago
Description
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
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