Where will I be working?
A progressive company, with a busy and ambitious future, offering a warm and welcoming, enjoyable working environment and culture.
What will I be doing?
My client is seeking a Senior Engineer (Facilities and Projects) for their new build Oxfordshire R&D Laboratory facility which is scheduled for completion in 2017.
Reporting to the Facilities Manager (with direct reporting to the Director of Facilities and EHS (UK) for any project work), this position will have a key role in supporting the facility operations by coordinating all aspects of maintenance, calibration and repair to ensure daily activity is aligned to meet the facility / corporate goals and objectives. This role will also partner with the Facilities, Production and Quality departments at the US site to review and develop best in class, standardised processes to service operations
Duties will include:
- 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.
- Take a leading role and have 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).
- Maintain proper files for all records and logbooks in compliance with cGMP and statutory requirements/guidelines.
- 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 procedures and statutory requirements (US FDA and ISO).
- Complete all assigned tasks following cGMPs, UK Environmental, Health and Safety Laws and Regulations.
- 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.
- Project Engineer for implementation of capital budget items and large-scale projects to improve safety, quality, efficiency, cost reductions, production capacity and equipment availability.
What skills, qualifications & experience will I need?
- BEng Engineering or equivalent (Mechanical or Electrical preferred and either currently CEng or working towards CEng) or alternative Engineering qualifications with at least 10 years’ experience.
- Sterile or aseptic Pharmaceutical Manufacturing environment experience required.
- Experience with and working in Clean rooms: ISO Grades 5 – 8 European grades A – D Maintenance & Calibration Management.
- Familiarity with Water for Injection systems, HVAC / Clean room operation and processes highly desirable.
- Strong knowledge of drug cGMP and regulatory issues is required.
We really hope this great role appeals to you and you decide to apply! We love hearing from you and really appreciate every single application that we receive. We wish we could respond to your CV personally but due to the high number of responses we receive this just isn't possible. Therefore if you haven't heard back from us within a week, your application won't be taken any further on this occasion. Thank you so much for taking the time to respond to our roles. We wish you all the very best for your job search.
The Purely Recruitment Company is an Equal Opportunities Employer and operates as an Employment Agency for permanent recruitment and an Employment Business for temporary recruitment.