Do you want to work for an organisation that has a strong heritage of solving the toughest challenges, through a combination of innovative products and a focused practitioner support, and one which ultimately brings a fresh perspective to the marketplace? If so, this may be the role for you.
We are looking for a Microbiology Manager to join a well-established team. Within this role, you will be the department manager of a team of four self-sufficient Microbiologists and have an oversight of supporting a GMP sterile manufacturing site. The Microbiology Manager will developed knowledge and understanding of ISO and regulatory standards necessary to control and release products according to medical device and sterile product manufacturing requirements.
Reporting to the Head of QARA, your role will include:
- Ensuring the classification status of the environment remains appropriate in accordance with the applicable ISO 13485 and regulatory standards.
- Ensuring appropriate viable and non-viable environmental monitoring is performed in the manufacturing and filling environments; and producing batch specific, quarterly trending and annual statistical analysis reports with this data.
- Co-ordinating dose audits and dose mapping validation and testing for irradiation of primary packaging components.
- Co-ordinating disinfection and preservative efficacy testing.
- Generating standard operating procedures and training documentation; and implementing training programmes for microbiologists and personnel entering the manufacturing and filling rooms.
- Performing non-conformance and CAPA investigations for out of specification results and compliance issues.
- Performing change controls for process and facility changes.
- Actively participate in and support regulatory audits including FDA, TUV SUD, MDSAP and UL.
- Generating validation documentation for new processes and test method validation.
- Active member of the Quality Assurance Extended Leadership Team.
- Ensure compliance with GMP, GLP, procedures, Regulatory Guidelines and Environmental Health and Safety requirements.
- Interpret data and review and approve method suitability and testing as required for products or processes in line with the required guidelines.
- Active member of the standards committee; performing gap analysis for ISO standards against current procedures and practices.
Skills and Experience Required:
- Life Science Degree i.e. Microbiology or equivalent
- Experience of working in a sterile, aseptic environment
- Detail-oriented and excellent written and verbal communication skills
- Ability to plan and manage workload
- Strong interpersonal skills and the ability to work as part of a team
- Ability to manage employees
- Experience of ISO 13485 and GMP standards
If this role interests you, then please apply now. You can submit your CV and cover letter highlighting your expertise as a Microbiology Manager. We will send you a confirmation of acknowledgement, and please note feedback can take up to 2-3 weeks. Upon successful selection for an interview, the process will occur in the following three stages:
First stage: This will be an initial screening call with a Life Science People representative
Final stage: A video call with the hiring manager - Head of QARA and HR Business Partner to go through your background and experience in relation to the role
The Microbiology Manager role is a full-time permanent position, paying up a competitive salary & benefits package. You will be based on site in one of their facilities in Kent. Full details will be provided on application. In addition to a generous basic salary, the company offers the following benefits package:
- 25 days holiday, plus bank holidays
- 5% employee 9% company contribution
- Private medical - self only
- Eye care discount
- Absence management scheme, group income protections
- Life assurance X4 annual,
- MIP bonus - 10% personal based