Operations Engineer - Stevenage
Alex Tosney is currently recruiting for an Operations Engineer to join a major initiative to grow a cell therapy industry delivering health and wealth for the UK. Its vision is for the UK to be a global leader in the development, delivery and commercialisation of cell therapies, and a place where collaborating businesses can start, and confidently grow. This role is offered on a full time permanent basis with a salary circa £35,000.
The company have developed a £55 million UK cell manufacturing centre based in Hertfordshire and the purpose of this facility will be the GMP manufacture of cell and gene products for Phase III clinical trials, to augment the current UK manufacturing capability. This large scale manufacturing centre will supplement the process development and scale-up capabilities already established in-house at the company's development laboratories in London for collaborators by offering the space, equipment and support for them to move into manufacturing.
The main responsibilities in this role will be:
- To partake in the facilities and engineering area quality compliance systems and ongoing improvement in quality performance and right first time culture. This will be in accordance with statutory, regulatory and company standards, procedures and systems regarding relevant cGMP and Quality Systems in the workplace.
- To ensure the availability and reliability of building utilities, services and manufacturing equipment for the operational areas in order to achieve the plans to satisfy collaborator requirements. This will be achieved through the alignment and provision of facility and engineering resource in accordance with the business plan.
- To identify and implement technology based and working practice solutions designed to reduce the overall cost per unit measures.
- To participate and contribute to Practical Process Improvement (PPI) projects that deliver the business objectives in a cost effective manner.
- The delivery of the Engineering Maintenance Strategy in a safe, quality-focused and cost-effective manner. Specifically, to undertake a Preventive and Predictive maintenance strategy for all of the assets on site.
- Work to Good Engineering Practices (GEP) within the Maintenance Engineering department, including engineering standards, housekeeping, adherence to business processes, and both GMP and Safety risks.
- Follow the Work Order Management process, so as to drive efficient execution of maintenance tasks through detailed planning and scheduling.
- Undertake high levels of PM and Calibration Schedule Compliance.
- Partake in the processes for reviewing failure history and work order data in order to create, monitor and act of equipment performance trends.·Interact with support teams via formal meetings and as required on an ad hoc basis to ensure the efficient running of the business.
You are required to have the following qualifications, skills and experience:
- Experience of working within a GMP Engineering/Facilities management team in a phase III / commercial biologicals, vaccines, cell or gene therapies, pharmaceutical manufacturing facility ideally within a large multifunctional site.
- Experience of working with commercial clients and collaborators
- Proven knowledge of EU/MHRA/HTA/HFEA and FDA regulatory requirements
- Proven knowledge of Environmental and Health and Safety legislation within the pharmaceutical / biopharmaceutical industry
- Experienced in first line diagnostics in M & E systems
- Proven understanding of Building Services, M&E systems, building fabric and BMS, EMS systems and operation
- Proven first-hand experience of working with PPM Systems
- Educated to degree level or an equivalent recognised professional technical qualification
- Member of relevant professional institution e.g. CMI, CIBSE, BIFM, CIOB and evidence of continued Professional Development (CPD)
If successful you will be joining the newest part of an initiative that is the UK's response to the translational gap between early-stage research and the later stages of clinical development in regenerative medicine.
For more information or to apply for this Operations Engineer position please contact Alex on +44 (0)1246 457 718 or email Atosney@ckengineers.co.uk. Alternatively, please click on the Apply button below to apply online now.
CK Engineers is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ENG38430 in all correspondence.