- Job Title: Deputy Manager Engineering – Pharma GMP
- Salary: Up to £37,000 dependent on experience, plus excellent benefits (bonus, pension (10% company contribution), private medical cover, life assurance plus others)
- Location: Stevenage
- Role Purpose: To support the Head of Engineering in the Set Up the Department at this new GMP Manufacturing Facility with a Focus on Quality and Compliance to then Take Ownership of These Functions.
- Ideal Role for Anyone Seeking an Opportunity to take a Step Up in Their Career.
James Hume is recruiting for a Deputy Manager to join the Head of Engineering in the establishment of the team and processes at this new GMP manufacturing site in Stevenage. This role will have a focus on the compliance and quality functions of the new team, to then take on the responsibility for the management of these systems when the centre opens later this year.
The company are a centre of excellence for the development of cell and gene therapies industries, providing support for the development and manufacture. This role is to be based at their new Stevenage manufacturing facility that will offer manufacturing services on a scale large enough for phase III clinical trials. This facility comprises of Grade A and B clean room laboratories as well warehousing, segregated manufacturing areas and business offices totaling 7,200m2. This facility is currently under construction and due to be operational in late 2017.
This is a senior role that will play an important part in establishing the engineer function at this new facility where will establish the processes to be followed, SOP’s, RFT culture by working closely with the Head of Engineering and other senior managers e.g. quality. The scope of the role covers both the hard and soft services within the centre to ensure services and building functions are available. The focus will at first to be set up the department but this will then change once the centre has been opened to take ownership of these functions. In addition to this you will also manage the relationships with contractors ensuring their work is completed on time, to the right standards and compliance. There is an operational aspect to this role when necessary and will suit a multi-skilled engineer but the larger focus is on the compliance management of the site.
Desired Skills and Competencies:
For this role you will need to have prior experience of working in a GMP compliant engineering / facilities management team from a broad range of environments such as phase III / commercial biologics / vaccine / cell & gene therapy / pharmaceutical manufacturing site. With experience of first line diagnostics in mechanical & electrical systems with demonstrable understanding of building services & fabrics as well as BMS, EMS systems. In addition you will have experience of working to MHRA / FDA / HTA / EU regulations.
Facility, warehouse, vendor, SOP, user requirement specifications, USR, validation, document, manage, management, facility management, hard, soft services, health and safety, GMP, EU, MHRA, FDA, pharmaceutical, biopharmaceutical, cell therapy, biologics, vaccine, PPM, commission, calibration, validation, budget, waste, cleaning., grade C, CNCBMS, HVAC, electrical, health and safety, H&S, logistics, ERP, SAP, manage, supervisor, supervisory, CAPA, goods in, goods out, dispatch, inspection, inventory, audit, cleaning, laundry, waste transfer, hydrogen peroxide, contractor, MBR, NC, CAPA, Kanban Facility, management, facility management, hard, soft services, health and safety, GMP, EU, MHRA, FDA, pharmaceutical, biopharmaceutical, cell therapy, biologics, vaccine, PPM, commission, calibration, validation, budget, waste, cleaning., grade C, CNCBMS, HVAC, electrical, health and safety, H&S, mechanical, HTA, HFEA, EU, GEP, good engineering practice, utilities, PPI, mange, supervise, validation, fire safety.