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Equipment Maintenance Specialist

3 months ago


Stevenage, United Kingdom Achilles Therapeutics Full time

Achilles is a fast paced, trail blazing bio-technology company focussed on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer company. Originating from pioneering research at Cancer Research UK (CRUK), the Francis Crick Institute and University College London (UCL), we use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient. From this, we develop personalised T cell therapies and currently have two programmes in the clinic for the treatment of Lung Cancer and Metastatic Malignant Melanoma.

As no-one has done what we are doing before, there is no playbook to copy. This means we must innovate, adapt and collaborate across our organisation, working together to solve novel problems. This entrepreneurial spirit and approach runs through our company and those who thrive here are able to cope with anything that is thrown at them, enjoy making sense of ambiguity and thrive on making things happen even when there is not a detailed brief.

Role Summary:

We are looking for someone to be responsible for the maintenance and calibration of Achilles manufacturing equipment in the Cell and Gene Therapy Catapult to support ongoing GMP manufacture.

The role will be Monday to Friday, with occasional cover to support on-call rotas and planned weekend activities.

Key Responsibilities:

  • Develop, plan and execute PPM & calibration activities for Production equipment (including incubators, fridges, freezers, isolators, centrifuges etc.) to ensure zero stoppages.
  • To maintain the Equipment Lifecycle Spreadsheet (ELS) and ensure it is kept up-to-date with latest calibration and maintenance dates.
  • Ensure equipment is correctly labelled as per maintenance and calibration status and is updated as required post maintenance and calibration.
  • Liaise with equipment SME’s to renew equipment service contracts.
  • Ensure external engineers are booked in advance as per the ELS schedule to attend site to maintain, calibrate, repair equipment.
  • To ensure visiting engineers are aware of and adhere to site requirements including provision of RAMs, site inductions and are issued permits to work.
  • To manage contractors on site, monitor, manage and review activities and ensure that all PPM documentation is reviewed, approved and securely filed in applicable Equipment Master Files.
  • Be capable of providing initial first assessment for any equipment issues. To be capable of liaising with equipment providers to safely diagnose issues and expedite repair to minimize downtime.
  • To implement systems for tracking and reporting equipment performance, deviation logs, down-time trackers for implementing further preventative actions.
  • Lead the assessment, identification, ordering and maintaining critical equipment spares and tools.
  • Operate Achille AMICII system to raise POs and and approve invoices once works are complete.
  • Be part of the Achilles on-call team for out-of-hours support as required.
  • Provide status updates related to equipment maintenance and calibration in weekly meetings and as required.
  • Write, review and update maintenance SOPs as required.
  • Adhere to all applicable Achilles Policies, SOPs and H&S processes.

Requirements

  • Demonstrable experience of working on the maintenance and calibration of manufacturing / laboratory equipment in a GxP environment.
  • Bachelor of Engineering or HNC/D with hands on mechanical and electrical experience
  • Experience of managing PPM activities in Biotech / Pharma setting.
  • Capable of providing initial first assessment for any equipment issues to safely diagnose issues and expedite repair.
  • Health and safety knowledge including risk assessments.
  • Experience of working within the requirements of a Quality Management System.
  • Equipment lifecycle knowledge
  • Knowledge of maintaining Grade A isoloators is highly desirable.

Benefits

At Achilles you will enjoy a flexible and dynamic working environment that fosters creativity, leadership, and teamwork. We work hard and deliver a lot

Our benefits package includes a competitive salary and performance related bonus, group pension plan matched up to 6%, life insurance, private medical insurance, and a tax approved all employee share incentive plan.