Job Title: Microbiological Support Specialist
Duties and Responsibilities:
• Provide microbiological support to the site, ensuring compliance with quality and regulatory requirements.
• Develop, maintain, and update microbiological methods, specifications, and SOPs for GMP environment execution.
• Trend data, monitor Out of Specifications, and participate in laboratory investigations.
• Conduct testing of In-process, Drug Substance, and Drug Product Batches manufactured on-site.
• Coordinate all site Utilities testing-environmental monitoring and water testing programmes.
• Lead environmental investigations, root cause analysis, and report close-out activities.
• Facilitate monthly environmental review meetings and present trends to a cross-departmental team.
• Provide annual contamination control training to all personnel and aseptic technique training to new employees.
• Validate microbiological methods, such as bioburden and endotoxin testing.
• Support autoclave validation programme and stability testing of Drug Substance and Drug Product Batches.
• Participate in Quality and Safety regulatory audits and raw material testing for GMP manufacture.
• Collaborate with vendors to ensure equipment qualification and validation, input into identifying equipment requirements, and troubleshoot equipment and techniques within the Analytical team.
• Engage in other projects/duties as defined by the Quality Director.
Position Specification:
• Third-level degree in a life Science discipline required.
• 2-5 years' experience in a microbiology role with relevant experience in environmental monitoring, utilities testing, bioburden testing, and endotoxin testing.
• Strong analytical and technical skills, ability to learn quickly, and take responsibility for tasks/projects.
• Highly organized and structured approach to task completion, strong time management awareness, and ability to drive projects forward.
• Excellent verbal and written communication skills, including presenting work in clear, concise reports or presentations.
Benefits:
• Competitive salary, bonus, 25.5 days holiday per annum plus public holidays, defined contributory pension plan, private medical insurance for you and your family, and empowered flexible working.