Role Purpose:

To support the transition of in vitro diagnostic (IVD) products from R&D into scalable manufacturing by executing and improving development-scale production processes. The Development Technician will work closely with R&D scientists, engineers, and manufacturing personnel to ensure that processes are robust, reproducible, and compliant with quality and regulatory standard

The Manufacturing / Development Technician will work closely with R&D scientists, engineers, and manufacturing personnel to ensure that processes are robust, reproducible, and compliant with quality and regulatory standards.

Key Responsibilities:

· Set up, operate, and troubleshoot equipment and instrumentation on the development manufacturing line.

· Perform technical tasks such as reagent mixing, filling, cartridge assembly, functional testing, and packaging in accordance with batch records and protocols.

· Record experimental and manufacturing data accurately, including completion of batch documentation and deviation logs.

· Assist engineers and scientists in trialling and optimizing manufacturing processes and equipment.

· Provide feedback on process issues and opportunities for improvement based on hands-on experience.

· Work in compliance with Good Manufacturing Practice (GMP), ISO 13485, and other relevant standards.

· Participate in investigations, root cause analysis, and CAPAs for process deviations or non-conformances.

· Support validation activities including IQ/OQ/PQ and documentation generation.

· Collaborate with R&D, Quality and Engineering teams to support the development and launch of new diagnostic tests.

Required Qualifications & Experience:

Essential:

· GCSE/A level qualifications

· Ability to use Microsoft software packages

Desirable:

· Experience in a regulated manufacturing or laboratory environment (ideally within IVD, medical device, or pharmaceutical /Production sectors).

· Hands-on experience with technical equipment, instrumentation, or diagnostic product assembly processes.

· Prior involvement in process development or pilot manufacturing activities.

· Knowledge of ISO 13485, cGMP, or FDA QSR requirements.

· Experience with lean manufacturing tools or continuous improvement initiatives.

Key Competencies & Behaviours:

· Attention to Detail: Accurate completion of technical tasks and documentation.

· Problem Solving: Ability to identify issues, perform basic troubleshooting, and contribute to process improvements.

· Teamwork: Willingness to work flexibly in a cross-functional team environment.

· Technical Aptitude: Strong mechanical or process understanding with a willingness to learn new equipment and procedures.

· Initiative: Proactive in seeking improvements, raising concerns, and suggesting solutions.

Working Conditions:

· Primarily laboratory and controlled manufacturing environment.

· May involve shift work or flexible hours to support development timelines.

· Use of PPE and adherence to safety protocols required.