Why this role is important for CPI’s
work
CPI are looking to appoint a Microbiologist to support the quality assurance environmental monitoring strategy for CPI Biologics GMP Facilities, promoting and integrating quality into every aspect of our business, providing environmental and microbiological expertise into the quality management system (QMS) for the CPI Biologics RNA Centre of Excellence and the Nigel Perry Building at Darlington.
The microbiologist will perform a variety of tasks in support of specific areas of the site quality assurance function mainly focusing on the collecting, analysing and reporting data on environmental conditions to ensure the cleanrooms met the classification as determined by ISO and Annex 1.
They will work closely with manufacturing and quality teams to identify potential contamination risks and contribute to the development and execution of contamination control strategies for the CPI Biologics RNA Centre of Excellence facility and the Nigel Perry Building GMP Areas to meet Good Manufacturing Practice (GMP) requirements.
Key tasks in the Microbiologist role will include (but are not limited to the below), please download the job description for full details available on the :
1. To maintain consistent and documented compliance with all relevant Safety, Health and Environmental (SHE), Good Manufacturing Practice (GMP), Data Integrity (DI), quality and best practice requirements.
2. Perform routine environmental monitoring of cleanrooms and managing outsourced EM activities in accordance with GMP guidelines taking the appropriate actions to manage deviations and OOS results.
3. Assures that Environmental Monitoring operations are conducted in compliance with facility procedures and regulatory guidance.
4. Support in the resolution of environmental issues to support the release of products.
5. Perform root cause investigations and quality risk assessments to GMP standards.
6. To support the development and execution of the control strategy and site master file for CPI Biologics GMP facilities to ensure they are current and appropriate to the activities being undertaken.
7. To undertake hygiene risk assessments for facility, utilities and project specific processes.
8. Support the technical transfer of projects into the GMP facility to ensure compliance to GMP requirements and the CPI Biologics control strategy.
9. Support regulatory and customer audits as a GMP SME for Environmental Monitoring.
10. • Author, review and approval of policies, SOPs, work instructions and other quality documentation.
The person we are seeking
Essential:
11. Educated to HNC or Foundation Degree level (or equivalent) in a Scientific/ Engineering discipline plus significant industrial experience at a senior level OR Educated to Degree level (or equivalent) in a Scientific/ Engineering discipline plus significant industrial experience.
12. Will possess microbiology and or environmental monitoring expertise in a GMP environment.
13. Experience of operating within a GMP environment, applying routine systems for environmental monitoring activities.
It would be great if you also had:
14. Degree in Microbiology.
15. Chartered status with a relevant professional institution.
What does CPI offer you?
At CPI, we offer a wide range of benefits to our employees, this includes:
16. Up to 36 days holiday, including bank holidays – Plus a holiday purchasing scheme
17. Generous pension scheme
18. Life assurance and accident insurance schemes
19. Flexible working
20. Learning and Development Opportunities
21. Free parking