Instrument Engineer - GMP Manufacturing & Lab

Instrument Engineer - GMP Manufacturing & Lab

Job Title: Instrument Engineer - GMP Manufacturing & Lab
Contract Type: Permanent
Location: Stevenage
Salary: Around £40k + 15% shift allowance + annual bonus + excellent benefits
Start Date: 2020-09-28
Reference: V-46391
Contact Name: Steve Twinley
Contact Email:
Job Published: September 29, 2020 07:55

Job Description

Do you have an Engineering background, with expertise in instrument calibration, gained within a regulated Pharmaceutical clean room production and / or lab environment? Two brand-new roles have been created in Stevenage, Herts, for Instrumentation Engineers, to provide engineering support to automated manufacturing and QC operations within a modern Cell & Gene Therapy GMP manufacturing facility, to help develop new cancer treatments.
These are permanent positions with a very competitive salary (around £40k or slightly higher, plus 15% shift allowance, plus annual bonus and excellent benefits) and this will be a great opportunity to build on your experience and develop your career.
You will work on an alternating double day shift pattern (6am-2pm Mon-Fri for a week, then 2pm-10pm Mon-Fri for a week). There is no weekend work, apart from being on call one weekend in four.
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 automated 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 (or slightly higher depending on experience) plus 15% shift allowance, plus annual bonus, plus benefits.