Microbiology Laboratory Manager (Facilities and Clean Rooms)
£33,500 - £35,000 + attractive benefits + generous pension
I am recruiting for a Microbiology Laboratory Manager to take charge of the water and environmental monitoring at a production facility manufacturing patient therapeutics. This is a critical role, with an excellent package, attractive location and a real chance to have an impact on a thriving business.
Essential to be successful in this role is strong prior experience in this type of position and environment. The laboratory uses extremely hazardous chemicals and solvents, as well as bacteria and fungi, and tests toxic and potent drugs which require handling with extreme care. A high level of technical skill level is required for this testing to protect the operator and environment.
Provide a professional lead for the environmental monitoring (EM), identification and water system aspects of the Microbiology Laboratory and wider production facilities.
Ensure all staff are fully trained and equipment used for EM and identification is serviced, calibrated and maintained as required.
The role is critical in ensuring that environmental compliance in the facility is maintained which in turn enables the manufacture of high quality products to patients.
- Facilitating the smooth and efficient day to day running of the facility, and undertaking of the environmental monitoring and identification
- Ensuring that all requirements and timescales are met- this requires following appropriate changing procedures to access clean rooms with restricted access
- Continually monitor the service provision and suggest improvements to keep in line with current regulatory compliance
- Implementation of changes to ensure objectives and deadlines are met through the formal change control system or other routes as deemed appropriate
- Own and manage the temperature monitoring system which is used to monitor the temperature and humidity of critical areas of production
- Solving problems and queries for environmental and water system monitoring routine and non-routine work
- Manage investigations of all environmental and identification of "out of specific" results
- Manage and approve environmental and identification non-conformances
- Own, review and implement facilities (water system and EM) and identification documentation including work instructions and forms
- Review and approval of results for identification from the Vitek 2 Compact System and bacterial endotoxin results from the Endoscan-v system
- Undertake bacterial endotoxin testing of water samples, finished product and active substance samples
- Reviewing and approving pressure differentials and air change rates for Microbiology Clean rooms and production clean rooms ensuring rooms are suitable for use and compliant
- Generation of clean room annual review
- Provide specialist knowledge to ensure clean rooms are maintained to the required standard including undertaking inspection reviews to ensure GMP compliance
- Provide specialist Technical advice as required to internal and external auditors including the MHRA and notified body, internal and external customers
- Management of the environmental monitoring and identification team including undertaking development reviews, sickness management and holiday requests
- Recruitment and selection of new members of staff and implementation of training plans as required for new and existing staff in environmental monitoring
- Training and competency assessments of Quality Control analysts in all aspects of environmental monitoring and identification. Countersigning any work from staff in training and signing each off as competent
- Selection of microbiology laboratory equipment including writing user requirement specifications and undertake validation activities in order for equipment to be put into use
- At least a degree in Microbiology, Pharmaceutical Sciences or a similar science related subject is essential
- Previous experience in lab management and management of clean rooms
- Proven track record in lab managemnt and/or facilities monitoring and compliance
- A detailed knowledge of EU GMP requirements for clean rooms is required
- Previously worked within quality control (preferable Pharmaceutical quality control)
- Knowledge and/or experience working to ISO14385 for CE marked devices
- Experience in identification of microorganisms
- Experience working within a quality system environment (GxP, ISO, etc)
- Ability to work to under pressure meeting the different job role requirements in agreed timeframes
- Ability to concentrate when work can be unpredictable
- Able to deal with the different emotions of people from different work areas and within own team.
Give me a call to discuss the role further.