Senior Moulding Validation Engineer
Confirmed on the employer's own hiring board on Nov 12, 2026. First seen by Alion on Nov 11, 2026. Danaher scores A on the Alion truth index.
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives-and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.
Learn about the Danaher Business System which makes everything possible.
The Senior Moulding Validation Engineer is responsible for planning, coordinating and executing global product validation activities associated with injection mould tooling changes, including new tooling, tool transfers, refurbishment, repair and major modifications.
This role acts as the technical validation lead, ensuring changes are implemented in compliance with ISO 13485, FDA and internal quality management system requirements whilst maintaining continuity of supply to global manufacturing operations.
What you will do:
- Lead global validation activities associated with injection mould tooling changes
- Develop and execute product validation strategies in accordance with internal procedures and applicable regulatory requirements
- Define product validation scope, acceptance criteria, sample sizes and statistical rationales for verification and validation activities.
- Review and approve product Validation protocols and reports.
- Create detailed project plans in collaboration with suppliers, Global Moulding Group and manufacturing sites
- Coordinate multiple validation projects simultaneously while maintaining commitments to quality, cost and delivery.
- Critically assess supplier-generated validation reports, dimensional studies, capability analyses and technical justifications.
- Actively participate in Continuous Improvement projects and Kaizen events
Who you are:
- Degree in Engineering or Science, or equivalent experience in a relevant field
- Experience in a Life Science oriented manufacturing company or similarly regulated industry
- Demonstrated experience leading validation of injection moulded products
- Strong project management and stakeholder management skills
- Understanding and experience of risk assessment and technical change control validation techniques within a regulated industry (ISO 13485)
- Strong understanding of statistical analysis, process capability and validation methodologies
- Ability to use structured problem-solving techniques to drive to root cause and sustain improvements
- Ability to prioritize, manage and complete projects with limited direction, on time and in full
Travel, Motor Vehicle Record:
- Limited overnight travel to manufacturing, supplier, and customer sites, typically within UK and Europe
- Must have a valid driver’s licensewith an acceptable driving record
- undefined
It would be a plus if you also possess previous experience in:
- Ability to communicate effectively across multiple departments and functions
- Knowledge of Lean Manufacturing concepts
- Knowledge of six sigma and the use of statistical tools
Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.