Instrument Automation & Calibration Engineer - GMP

Health Care/Medicine jobs >> Pharmaceutical

Negotiable

Permanent

Description

Do you have an Engineering background, with expertise in Instrumentation / Calibration, gained within a regulated clean room or aseptic Pharmaceutical production environment? A brand-new role has been created in Stevenage, Herts, for an Instrumentation / Automation Engineer, to provide engineering support to manufacturing and QC operations within a modern Cell & Gene Therapy GMP manufacturing facility. This is a permanent position with a very competitive salary (around £40k - £44k, plus excellent benefits) and this will be an excellent opportunity to build on your experience and develop your career.
 
Previous experience in a Biologics environment, where assay processes for proteins or antibodies have been automated, would be a very strong advantage. Control system (PLC) experience is essential, as is a good understanding of HVAC systems, medical gasses etc.
 
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. You will support and provide first fix capacity for manufacturing and analytical 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. This is a permanent role in Stevenage, Hertfordshire, paying £40k - £44k (depending on experience) plus benefits
  • 1
  • Negotiable
  • None
  • None
  • CV-101131
  • Permanent
  • 8

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