About Us
We are a dynamic and growing manufacturing business specialising in high-quality, regulated rapid diagnostic products. Operating under ISO 13485:2016, we are committed to excellence in every part of our operation—from development to production and distribution. With a strong customer focus and a collaborative team culture, we are now seeking an organised and proactive individual to manage technology transfer and associated validation activities while maintaining cross-functional alignment between manufacturing, quality, and operations.
The Role
We are seeking a hands-on Technology Transfer Specialist to support the transfer, qualification and validation activities of products and processes into manufacturing.
This role is critical in ensuring that equipment, systems, and processes operate within specification while enabling efficient, compliant, and scalable production. You will work cross-functionally with all departments to maintain compliance with ISO 13485:2016 and our internal Quality Management System (QMS).
Key Responsibilities
Technology Transfer
· Lead and coordinate technology transfer activities for new product introductions and process changes.
· Ensure readiness across all departments for successful transfer to production.
· Create and review Bills of Materials (BOMs) and related master data.
· Act as a key liaison between cross-functional teams to ensure smooth handovers and alignment.
Process Development & Optimisation
· Support process development, scaling, and optimisation to ensure robust and efficient manufacturing.
· Identify and implement improvements to enhance reliability, efficiency, and scalability.
Validation & Qualification
· Support the preparation, execution, and documentation of validation protocols (IQ/OQ/PQ) for equipment, processes, and systems.
· Assist in commissioning and qualification of new or modified equipment.
· Ensure all validation and qualification activities meet both customer and internal QMS requirements.
Documentation & Compliance
· Develop and maintain transfer and validation documentation, including protocols, reports, process descriptions, and risk assessments.
· Ensure all activities comply with ISO 13485:2016 and internal QMS requirements.
· Support internal and external audits by maintaining accurate and up-to-date documentation.
Training & Knowledge Transfer
· Coordinate and support training activities to transfer technical knowledge to Manufacturing and Quality teams.
Safety & Continuous Improvement
· Follow all company safety and regulatory requirements.
· Identify gaps or inefficiencies and drive continuous improvement initiatives across validation and transfer processes.
What We're Looking For
· Experience in technology transfer within a regulated manufacturing or laboratory environment.
· Strong understanding of ISO 13485:2016 or similar quality management systems.
· Familiarity with IQ/OQ/PQ validation protocols.
· Experience with product/process transfer and manufacturing scale-up.
· Knowledge of MRP systems and BOM setup.
· Strong attention to detail with excellent documentation and organisational skills.
· Hands-on, practical approach with strong problem-solving ability.
· Excellent communication and interpersonal skills, with the ability to work cross-functionally.
· Self-motivated and comfortable working in a fast-paced, team-oriented environment.
Why Join Us?
- Be at the forefront of bringing new, life-enhancing products from development to reality.
- Play a key role in shaping scalable, compliant, and efficient manufacturing processes.
- Enjoy a close-knit, friendly working environment where your contributions are visible and valued.
- Gain exposure to a wide range of operations within a regulated and innovative company
Ready to take your tech transfer skills to the next level?
Apply now with your CV and a covering letter outlining why you’re the perfect fit for this role.
Job Types: Full-time, Permanent
Pay: £32,000.00-£37,000.00 per year
Application question(s):
- Do you have experience in an ISO 9001 or 13485 environment
Work Location: In person