We are seeking a dedicated and detail-oriented Band 4 GMP Facility Officer to support the daily operations of our MHRA-licensed GMP unit. The postholder will play a vital role in ensuring the cleanroom environment (Grades B, C, and unclassified areas) ismaintained to the highest standards of cleanliness, compliance, and operational readiness for advanced therapy medicinal product (ATMP) manufacturing.
Key responsibilities will include performing routine cleaning of classified areas, conducting physical and microbiological environmental monitoring (EM), incubating EM plates and broths, ordering and receipting of production reagents and consumables, and maintaining accurate stock records. The role also involves documenting all cleaning, equipment servicing, and maintenance activities in line with the Unit’s quality management system (QMS).
The GMP Facility Officer will work closely with Production and Quality Control Scientists to ensure that cleanroom operations are compliant with GMP standards and support the timely and safe delivery of manufacturing activities.
Key Responsibilities
Cleanroom and Environmental Monitoring
• Perform routine cleaning of cleanrooms (Grades B, C, D, and unclassified) following GMP and SOPs.
• Carry out environmental monitoring (viable/non-viable particle counts), incubate media, and record results.
• Support contamination control efforts and qualification of EM and cleaning strategies.
Stock and Logistics
• Manage timely ordering, stock checks, and inventory of consumables, cleaning agents, and PPE.
• Maintain gowning supplies and arrange sample shipments to external labs.
Documentation and Compliance
• Accurately record all cleaning, EM, equipment maintenance, and servicing activities.
• Ensure operations comply with SOPs, timelines, and quality standards.
• Report deviations and complete related documentation.
Training and Team Support
• Support Production and QC teams to ensure seamless GMP operations.
• Train personnel on cleanroom practices (e.g., handwashing, spray & wipe).
• Promote teamwork and provide cover during staff absences.
• Attend departmental meetings and contribute to unit success.
Professional Development
• Engage in annual appraisals and maintain a Personal Development Plan (PDP).
• Participate in ongoing GMP, cleanroom, and quality systems training.
Other Duties
• Follow Trust and departmental policies, including health and safety.
• Perform other tasks as assigned to meet service needs.
The Advanced therapies Manufacturing Platform is co-located with the Clinical Research Facility (CRF) at Guy’s Hospital on the 15th floor of the tower. The GMP Unit is purpose built for the manufacture of Advanced Therapy Medicinal Products such as somatic cell therapies, gene therapies and tissue engineered products for early-phase clinical trials. It is used for both commercial and non-commercial clients as well as departments within GSTT and KCL to manufacture products related to trials undertaken in the CRF and at trial sites across the UK.
Please see the Job Description and Person Specification for detailed information regarding the responsibilities and requirements for this post.
This advert closes on Sunday 17 Aug 2025