Technical Administrator - GMP Engineering

Recruiter
SLS Services Limited
Location
Stevenage
Salary
32000.0000
Posted
18 Mar 2017
Closes
17 Apr 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
- Job Title: Technical Administrator – GMP Engineering
- Salary: Up to £32,000 dependent on experience, plus excellent benefits (bonus, pension (10% company contribution), private medical cover, life assurance plus others)
- Fixed Term Contract – 9 months
- Location: Stevenage
- Opportunity to Support the Construction of a Unique Cell and Gene Therapy Manufacturing Facility.

Overview:
James Hume is recruiting for a Technical Administrator to support the Head of Engineering by providing technical engineering and administrative expertise during the construction and opening of this unique manufacturing facility based in Stevenage.  The manufacturing centre is due to open later this year and its purpose is to develop and manufacture therapies at a scale large enough for phase III clinical trials.  They are currently nearing the end of the construction phase and this role will play a part during this phase and the handover once complete.

Company Summary:
The company are a centre of excellence for the development of cell and gene therapies industries.  They provide the technical expertise to be able to develop a therapy from concept to market launch for their collaborators who come from both academia and industry.  An overview of the services they provide includes laboratory, clinical, regulatory, access to NHS for the running of clinical trials and commercial expertise.  Ultimately they want to make the UK the logical choice for the development and commercialisation of these cutting edge therapies.

This role is to be based at their new Stevenage manufacturing facility that will offer collaborators manufacturing and process development services on a scale larger 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.  

The Opportunity:
This role is important within the engineering department because you will be working with the Head of Engineering and Facilities to provide technical administrative support to the department during the final construction and handover phase.  

The initial focus will be during the final construction phase to provide administrative expertise in defined process areas such as risk management, occupational health, data management and others.  Aside from the administrative duties you will worth with senior managers to assist with the development of policies and procedures for engineering activities.  As well as build an archive of all calibration, maintenance work undertaken to date including OEM to be created as part of the requirements for commission.

Once construction has been completed and the handover activities have taken place the focus of the role will change to duties relating to sub-contractors.  Such as technical agreements, contracts, scheduling maintenance activities, and the storage of RAMS, training files, and induction documentation.  You will also run the induction activities for all visitors such as contractors and others.

Desired Skills and Competencies:
For this role you will need to have prior experience of working in a GMP compliant engineering or facilities team in a similar role. With experience of handling GMP documentation with knowledge of environmental H&S, and quality systems within the pharmaceutical or biologics or biopharmaceutical industries.

Keywords
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.