The company were established in 2012 with the purpose to make the UK the place to commercialise Cell & Gene Therapies working in collaboration with partner based in the UK, Europe, US and Asia for example. The offer cutting edge technology, services, and capabilities to take a therapy across the translational gap. Then into the clinic, through clinical trials to launch.
They have now expanded to 3 sites with this role being based at their new Braintree facility which will be manufacturing therapies at a commercial scale and a COVID vaccine as part of the Government’s response.
Purpose of the Role:
The purpose of the role of Head of Engineering is to take responsibility for the management of the site from an Engineering perspective for both hard and soft services. Taking ownership of the strategy for the site, developing, and then implementing this in the short and longer term. Plus overseeing the day to day running of the site to ensure it is operational, managing a team of onsite engineers.
Key Responsibilities includes:
- Work with Senior Management and design team during the construction, commissioning, and validation of a new facility. To deliver this on time and on budget.
- Establish and then maintain a calibration and PPM programme that is compliant to GMP.
- Develop a close working relationship with the Quality Director to achieve MHRA approval for all engineering activities are completed in compliance with GMP
- Ensure all equipment that is purchased and validated for the Mechanical and Electrical systems is fit for purpose.
- Responsible for the day to day tasks to maintain effective operation of the site including all business critical systems through to planned maintenance.
- Manage the service teams including appraisals, training, succession planning for example as well as their day to day work.
Required Skills and Expertise:
- Experience of building and running and GMP engineering / facilities team.
- Experience of Biologics, Vaccine, Cell and / or Gene Therapy manufacturing facility
- Demonstrable experience of MHRA and / or FDA regulations
- Experienced of Hard and Soft Services, Health & Safety, M & E systems
- Membership of a relevant institutions such as CMI, CIBSE, BIFM, CIOB, is advantageous but not essential.