WALKER COLE INTERNATIONAL LTD

We are supporting a growing, global pharmaceutical manufacturer in the appointment of a Microbiology Manager, who will be responsible for microbiological oversight, team leadership, and ensuring compliance within a GMP-regulated environment. The Role You will lead microbiology activities across the site, ensuring environmental monitoring, testing, and quality systems meet regulatory expectations. The role combines technical responsibility with team leadership and cross-functional collaboration. Key responsibilities include: Leading and developing a microbiology team, including performance management and training Overseeing environmental monitoring programmes across manufacturing areas and utilities Supporting batch release through microbiological data assessment (EM, bioburden) Leading investigations (OOS, deviations, excursions) and implementing corrective actions Acting as the microbiology SME for site projects, including new methods, equipment, and processes Reviewing and approving trend reports, technical documentation, and microbiological data Authoring and reviewing SOPs, validation protocols, and reports Supporting method development and validation activities Collaborating with QA, production, and QC teams to ensure operational efficiency and compliance Driving continuous improvement and quality culture initiatives Requirements Degree in Microbiology or related scientific discipline Extensive experience within a GMP pharmaceutical QC environment Strong knowledge of USP, EU, and ISO regulatory standards Hands-on experience with microbiological techniques, including environmental monitoring, bioburden, membrane filtration, LAL/endotoxin testing, and microscopy Experience leading or mentoring teams Strong technical writing skills (SOPs, investigations, reports) Analytical mindset with the ability to interpret data and make sound decisions Effective communicator, comfortable working cross-functionally

Walker Cole International is searching for a Senior R&D Scientist - E&L and Nitrosamine Method Development - to join a global pharmaceutical company at their R&D and GMP-regulated site in the UK. As the Senior Scientist, you will play a key role in developing and validating analytical methods to support Extractables, Leachables, and Nitrosamine testing across pharmaceutical products and materials. Your responsibilities will include: Leading and supporting risk assessments and analytical method development for E&L and Nitrosamines. Developing, validating, and transferring LC-MS and GC-MS methods in compliance with GMP and regulatory guidelines. Performing data interpretation, troubleshooting, and technical investigations to resolve analytical issues. Preparing technical reports and regulatory documentation to support product filings and submissions. Collaborating with QC, QA, and Regulatory Affairs teams to ensure analytical compliance and product quality. Contributing to continuous improvement within analytical R&D and supporting method optimisation projects. To be successful, you will have: Proven experience in Extractables & Leachables and/or Nitrosamine analysis within a GMP-regulated laboratory. Hands-on experience with LC-MS or GC-MS and method validation techniques. Strong problem-solving, communication, and documentation skills. Analytical Chemistry Extractables & Leachables Nitrosamines LC-MS GC-MS Method Development Validation GMP Pharmaceuticals R&D

Walker Cole International is searching for a Process Technician to join a global pharmaceutical manufacturing business at their high-volume, GMP-regulated production site in Cambridgeshire. As the Process Technician, your responsibilities will include: Operating and monitoring pharmaceutical manufacturing equipment in compliance with GMP, safety, and environmental regulations. Carrying out raw material charging, basic equipment maintenance, and cleaning procedures to support batch production. Maintaining accurate production records and reporting any deviations or quality issues. Supporting investigations, process improvements, and updates to Standard Operating Procedures (SOPs). Collaborating with cross-functional teams and adapting to changing operational needs across multiple production areas. To be successful as the Process Technician, you will have: Experience in a GMP-regulated or manufacturing environment (pharmaceuticals or chemical manufacturing preferred). Strong attention to detail, communication, and observational skills. A proactive, team-oriented approach with the flexibility to work across different production zones. Willingness to learn and contribute to continuous improvement initiatives. A strong standard of written English and basic numeracy for documentation and reporting. Manufacturing Technician Process Operator GMP Pharmaceutical Production Cleanroom Regulated Manufacturing