Validation Technician – GMP Clean Room

About Instil Bio

Instil Bio is a cell therapy company developing tumor infiltrating lymphocytes (TIL) for the treatment of solid tumor cancers. TIL are a patient’s own T cells harvested from the patient’s tumor, which are then expanded and reinfused into the patient to target and kill cancer cells. Instil is advancing its proprietary TIL manufacturing expertise, technology, and data into clinical trials, including a planned registrational study with its lead candidate and a first-in-human study of its next-generation engineered TIL. The company is led by world-class cell therapy experts and backed by premier global institutional investors.

Instil Bio UK is Instil’s rapidly-growing, Manchester UK-based subsidiary. Our Manchester subsidiary has significant R&D, process development, and clinical manufacturing capabilities, with approximately 35 staff expanding to > 100 staff. Instil Bio UK has been generating cell therapy products for patient use since 2011, including TIL products and external partner genetically engineered T cell products.

Validation Technician

We now have an outstanding opportunity for an Validation Technician to join our Manchester based site where you will report to, and occasionally deputise for, the Facilities Manager. You will interact with the GMP manufacturing team, Process Development and third party contractors to support validation and maintain the operating capability of UK manufacturing and PD facilities (clean rooms, equipment, spare parts). 

Key Responsibilities Include (but not limited to):

  • Research, qualify and validate new equipment (process and facility) 
  • Set up and manage a schedule of all equipment maintenance at the Grafton Street site (CTU and Impact facilities)
  • As part of the Grafton Street Facilities team, own and manage the Grafton Street equipment asset register as part of the Quality Management System
  • Create and maintain a critical spare parts list
  • Provide first contact support to respond to equipment breakdowns
  • Produce and review of technical documentation for the facility or critical assets as part of the Quality Management System and regulatory requirements
  • Actively engage with the introduction, qualification and testing of new equipment products throughout the change control process
  • Participate in incident investigation and create incident reports for critical GMP equipment & facilities
  • Obtain & Manage Service contracts for the Facilities & Equipment
  • Where required train production staff in general equipment procedures
  • Assist with external engineers, including inductions, arranging parking, on site supervision & reviewing completed work
  • Help document and archive GMP critical equipment and facility documentation
  • Participate in reviewing and implementing facility, laboratory and asset management policies
  • Participate in fitting out and organising the planning of new laboratories when required
  • Organise and assist in routine operational testing of critical laboratory assets
  • Assist with facility cleaning, monitoring & disposal of waste 
  • Ensure compliance with COSHH and H&S Risk Assessments (associated with laboratories & assets) including assessment writing

Relevant Education Skills and Experience

To be successful in the role of Validation Technician it is anticipated that you will be qualified to degree level and have gained experience working in the Pharmaceutical or Biotechnology sector in a scientific, engineering or other technical discipline. 

With interactions across numerous different departments this role requires excellent communication and planning skills.

It is essential that you have a working knowledge of validation – preferably in a GMP accredited life science laboratory or production facility.

The following experience may be considered an advantage but is not essential:

  • Experience working in clean room environments
  • Knowledge of GMP/MHRA/HTA/H&S legislation
  • Knowledge of facilities management

Because of the nature of the role you must be able to move weights of up to 30KG with the aid of moving equipment.

Remuneration & Benefits

The salary for the Validation Technician will be competitive within the Biotechnology and wider Scientific sector with actual salary offered reflecting relevant qualifications and experience as well as performance at interview. In any event we anticipate a salary in the £25,000 to £35,000 range together with an attractive bonus and benefits package.

Application Process

If you would like to join us as Validation Technician at this critical time in our development and you think your skills and experience are a good fit for this role apply with a current CV and we’ll get back to you within a day or two.