THE POSITION
This position oversees and manages the daily operation of a laboratory focused on microbiology testing, environmental monitoring and water testing in a GMP manufacturing facility for animal vaccine. This is a fully-site based role in Pirbright.
TASKS & RESPONSIBILITIES
* Knowledge of aseptic process manufacturing (e.g. Annex 1) and expertise in environmental monitoring (viable and non-viable particles) of Grades A/B/C and D
* Responsible for laboratory tests such as TOC, conductivity, pH, growth promotion test, bioburden, bacterial identification
* Knowledge of contact/settle/active air sampling, APS, gowning qualification
* Knowledge of relevant chapters of the European Pharmacopeia and USP
* Lead and manage daily microbiology laboratory operations including supervision of lab team, scheduling work, training staff, and reviewing of data results and approval
* Perform troubleshooting, raise events/deviations, investigations, implementation of corrective actions and follow ups to ensure resolution
* Handling change controls
* Author, reviewer and approver of procedures and test methods
* Perform trending of EM data and writing of EM reports
* Author annual water trending report
* Be organized and maintain accurate record-keeping system
* Ensure adherence and compliance to GMP
* Support Microbiology instructor-led-classes for applicable personnel working in aseptic areas
REQUIREMENTS
* A minimum of B.S. degree in Life Sciences or equivalent
* Experience of working in a regulated analytical laboratory
* Knowledge of GxP quality systems
* Good Knowledge and experience of sterile manufacturing
* Proficient in Microsoft Office packages
* Organised, a team player, and a leader able to work to challenging deadlines
* Ability to supervise and develop others providing constructive feedback and development opportunities
* Champion and exemplify Boehringer Ingelheim's core values and behaviours across all interactions
* Foster a culture of continuous improvement by encouraging innovation and proactive problem-solving
* Collaborate effectively within the team, promoting shared success and mutual support
* Lead performance evaluations for direct reports, providing constructive feedback and development opportunities
WHY THIS IS A GREAT PLACE TO WORK
Boehringer Ingelheim has been recognised as a Top Employer in the UK. Being certified as a Top Employer confirms our dedication to a better world of work, delivered through excellent HR policies and people practices. To learn more visit: https://www.boehringer-ingelheim.co.uk/careers/uk-careers/why-great-place-work
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