GMP Facility Officer

at  Kings College London

Job id: 085092. Salary: £37,332 – £42,099 per annum, including London Weighting Allowance.
Posted: 23 February 2024. Closing date: 07 March 2024.
Business unit: Faculty of Life Sciences & Medicine. Department: Comprehensive Cancer Centre.
Contact details: Joel Pope. joel.pope@kcl.ac.uk
Location: Denmark Hill Campus. Category: Professional & Support Services.
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Job description
The Cell and Gene Therapy, King’s (CGT-K) group manufactures a variety of Advanced Therapy Investigational Medicinal Products (ATIMPs) and starting materials, in state-of-the-art Good Manufacturing Practice (GMP) facilities for the treatment of cancer and rare diseases. This post supports the translation of cutting-edge medical research into clinical application. The position is based in a team with an excellent track record in both basic and translational research.
The GMP Facility Officer will work as part of the Facilities Team to ensure the CGT-K GMP facilities are fit for purpose and maintained in a manner to support the ATIMP and viral vector manufacturing activities. The role holder will also work closely with the Quality Assurance (QA) team to ensure the CGT-K facilities comply with the requirements of the Pharmaceutical Quality System (PQS) and with the Production team to ensure the manufacturing schedule can be maintained.
Tasks undertaken will include but not be limited to:
Organisation and booking of engineers/service provider to execute routine equipment and facility maintenance, service and annual requalification visits and emergency repair visits.
Liaising with KCL estates to ensure engineer permits to work are issued.
Ensure the planned preventive maintenance is carried out as per the schedule and the tracking system is kept up to date.
Carryout in-house equipment calibrations and IQ/OQ
Participate in writing change controls for facility and equipment and undertaking change control activities.
Assist the Facility Manager in maintaining equipment records in accordance with the PQS.
Undertaking daily logging of equipment and facility temperatures and acknowledgement of facility / equipment alarms on the Facility Monitoring System.
Take part in the investigation of facility alarms, out of specification events and quality exceptions and implement corrective and preventive actions in conjunction with the Quality Assurance team.
Draft quality system documentation including but not limited to Standard Operating Procedures and equipment validation documents.
Participate in internal audits.
The GMP Facility Officer will be responsible to the GMP Facility Manager.
This would be an excellent position for someone who wishes to develop a career within the operational management and maintenance of GMP cleanroom facilities.
This post will be offered on an indefinite contract.
This is a full-time post - 100% full time equivalent.
Key responsibilities
Day to day responsibility for ensuring equipment and facilities are serviced as per the planned preventative maintenance schedule, including booking engineer routine equipment & facility maintenance, requalification visits and emergency repair visits in line with applicable GMP and HTA requirements.
Day to day responsibility for liaising with KCL estates to ensure engineer’s/ service provider’s permits to work are issued and that engineer/service provider inductions are completed.
Accompany the engineers into the cleanrooms/controlled areas, including cleaning in of the engineer’s equipment.
Day to day responsibility for daily logging of equipment and facility temperatures.
Day to day responsibility for acknowledgement of facility / equipment alarms on the Facility Monitoring System (FMS) as per the FMS standard operating procedure.
Carry out in-house equipment calibrations or assist the Production Team as applicable.
Carryout in-house IQ/OQ of equipment.
Carryout in-house annual requalification of equipment.
Day to day responsibility for notifying staff of out of use equipment, labelling equipment and bring the equipment back in to use as per the standard operating procedure.
Be responsible for data backup in conjunction with QA.
Ensure equipment and facility records are maintained in accordance with the PQS.
Assist QA with the weekly facility authorisation.
Take part in the investigation of facility and equipment alarms, out of specification events and quality exceptions and implement corrective and preventive actions in conjunction with the Facility Manager and Quality Assurance team.
Participate in internal audits.
Participate in writing change controls for facility and equipment and undertaking change control activities.
Draft quality system documentation including but not limited to Standard Operating Procedures and equipment validation documents. Perform equipment validation and prepare summary reports.
Assistance in routine facility housekeeping activities including:
Weekly checks of the facilities and support areas to ensure they are maintained in a fit for purpose state.
Managing of laundry including receipt and packing for sending.
Waste management.
The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.
Skills, knowledge, and experience

Essential criteria

• Educated to degree level or equivalent
• Experience in maintaining databases, tracking spreadsheets or inventories
• Experience in liaising with external and internal suppliers, contractors, service providers or stakeholders
• Experience of working in or maintaining a cleanroom environment
• Experience in equipment IQ/OQ, routine maintenance and / or calibration
• Experience in working to SOPs or written formal instructions
• Working knowledge of formal quality systems for change control and deviations
• Excellent organisational skills with demonstrable ability to balance competing demands and priorities
• Demonstratable experience of problem solving
• Experience of writing health and safety risk assessments and COSSH

Desirable criteria

• Experience of all aspects of QA/QC in relation to production of ATIMPs in particular Change Control, Document Control, Process Validation, Equipment Management CAPA, Quality Risk Management
• Working knowledge of a facility monitoring system

Further information
This post is subject to Disclosure and Barring Service and Occupational Health clearance.

Please refer the Job description for details