Control system (PLC) experience is essential, as is a good understanding of HVAC systems, medical gasses etc. Previous experience in a Biologics environment, where assay processes for proteins or antibodies have been automated, would be a very strong advantage.
You will join a pioneering company that is developing and manufacturing cancer treatments using next-generation T-cell therapies. They have a state-of-the-art production and testing facility which follows strict GMP regulations and aseptic standards. They have an excellent reputation as an employer and you will be part of something that will be genuinely life-changing for a lot of people. The company is easily accessible, on the outskirts of Stevenage, and provides ample parking.
Reporting to the Director of Site Facilities and Engineering, you will help to develop engineering processes and systems including asset management, maintenance and continuous improvement. This is a very hands-on position in which you will support and provide first fix capacity for manufacturing and analytical lab equipment and will work on a number of ongoing projects, as well as responding to immediate issues to help maintain smooth running of automated systems for assays.
Your role will include:
- Managing the introduction of new equipment
- Managing external contractors (including monitoring and reviewing activities and subsequent paperwork)
- Writing, reviewing and updating maintenance procedures for equipment and systems
- Working within the QMS to ensure correct processing of deviations, change controls and CAPAs
- Supporting the Validation team for requalification activities
You will work in partnership with engineering, production and quality teams and this will be a pivotal role for the smooth running of production and QC, especially as the company continues to grow.
Skills and Experience Required:
- Good qualification (HNC / HND / BSc) in an Engineering discipline
- Strong experience of Instrumentation / Calibration gained within a regulated clean room environment (ideally GMP Pharmaceutical)
- Knowledge of aseptic / sterile processing would be a strong advantage, as would experience from a biologics environment for antibody / protein processing or similar
- Strong IT skills and Control System (PLC) experience
- Ability to manage external contractors
- Excellent communication skills and ability to work with people at all levels
Full details will be provided on application. There are two permanent roles available in Stevenage, Hertfordshire, each paying £40k - £44k (depending on experience) plus benefits.