Senior Engineer Facilities and Projects 66

Reporting to the Facilities Manager (with direct reporting to the Director of Facilities and EHS (UK) for any project work)

• Ensure proper maintenance, calibration and repair of all facility equipment and systems including WFI system, HVAC and Clean Rooms, dry heat and steam sterilization systems, laboratory equipment and warehouse.

  Champions the preventive and predictive maintenance programme, reviews equipment history for reliability concerns, identify reliability improvement opportunities and applications for predictive maintenance technologies to reduce maintenance costs.

• Takes a leading role and has major involvement in the development and engineering of a potential new build dedicated European manufacturing facility and future expansion of that facility. Provides a supporting role to the expansion of the US facility (to include additional culture, processing suites and laboratory expansion over the next few years).

  Support to US operations as and when required.

  Manage outside contractors and supplies as needed for completion of projects, preventative maintenance, and calibration work. Service Contracts - work internally and with vendors to develop and maintain service contracts to support the maintenance programme.

• Maintain proper files for all records and logbooks in compliance with cGMP and statutory requirements/guidelines.

  Maintain critical Asset Management Program for equipment identification program, calibration, and maintenance (CMMS).

  Ensure that all cGMP automation equipment have the minimum documentation as per the ISPE GAMP5 guidelines. Help to ensure all documentation follows GMP, and are generated in compliance with Adaptimmune's' procedures and statutory requirements (US FDA and ISO).

  Complete all assigned tasks following cGMPs, UK Environmental, Health and Safety Laws and Regulations.

  Authors Standard Operating Procedures and job plans and assists in training development for others.

  Ensure that all engineering/facilities SOPs are up to date, perform annual system review for systems, assist quality during Non-Conformance investigations, and help reach closure on Corrective Action Preventive Actions (CAPA). Supports timely closure of facility related GMP deficiencies including audit observations, corrective and preventative actions (CAPA) and deviations.

• Keeping the Director of Facilities, VP Manufacturing and VP Quality advised as to status of assignment(s) with respect to schedule, budgets, delays and adverse problems.

  Providing technical assistance and guidance to other disciplines and other departments throughout the facility.

  Ensures that all appropriate documentation, drawings specifications are current.

  Establish and maintain positive and cooperative working relationships with other departments and facilities.

  Provide technical support to all departments within the facility and company's other sites as requested.

  Assist with the preparation of the Capital Expense budget and produces the Operating Expense budget related to engineering and maintenance/calibration functions for following year.

  Prepare capital expense requests for submission for approvals.

  Monitor expenses for areas of control to adhere to approved budget.

Project Engineer for implementation of capital budget items and large-scale projects to improve safety, quality, efficiency, cost reductions, production capacity and equipment availability.

Prepare and execute validation documentation for equipment (URS, DQ, IQ, OQ, IOQ, PQ) as required in support role to Quality department.

Deputise for Facilities Manager during absences.

Qualifications and Experience

Required -

• BEng Engineering or equivalent (Mechanical or
  Electrical preferred and either currently CEng or working towards CEng) or alternative
  Engineering qualifications with 10 years' experience.

• 
  Occasional overseas travel to the US and Europe to support the business activities.