- BBBH783246 May 25, 2021 Competitive
A fantastic opportunity to join a multinational Medical Device company in Cork as a Senior Staff Microbiologist. See below to apply today!
We are now hiring a Senior Staff Microbiologist for a Multinational Medical Device company in Cork.
The Senior Staff Microbiologist will be responsible for providing technical input regarding the relevant regulatory requirements and standards for medical devices, at a multi site / global level. The staff microbiologist will oversee and act as subject matter expert / technical lead in all areas of microbiology and ensure sustained levels of compliance.
Responsibilities: Will work within the microbiology team, with responsibility to ensure effective and efficient sterility practices, which includes, but not limited to the following:
- Oversight of environmental & utility monitoring, bioburden and endotoxin testing practices and procedures, creating alignment and standardization across multi-sites.
- Interpreting sampling and monitoring data, applying statistical and analysis techniques, to determine control and trending. Identifies and initiates when to take action.
- Lead technical input to NC and CAPA resolution within the microbiology group and across multiple business units. Strong competency in assessment of effectiveness and resulting sterility compliance. Review and approval of CAPA.
- Act as technical lead for microbiology in cross functional groups including product and process issues, root cause, projects, initiatives and other business critical forums.
- Subject Matter Expert, audit and review of Supplier quality activities with critical vendors in the area of microbiology.
- Review and approval of sterilisation validations and re-qualifications in line with relevant BS EN ISO standards. Assessment of sterility supplier validation.
- Continually identifies opportunity for stabilization of trends, statistical control of processes to allow cost saving.
- Mentors and trains team and cross functional groups as required (induction, GMP etc) and coach, mentor and train other functions in the area of sterility and monitoring.
- Subject matter expert to internal & external regulatory requirements, (including but not limited to European RHQ, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements)
- Subject matter expert to multi-site procedures, contribute to the development, maintenance and improvements of the policies and procedures to align to best practices, benchmarking against industry leads and regulatory requirements.
- Support of, ensure compliance of new products to sites' sterility standards. Ensure successful integration of products into validated processes.
- Oversight & approval of biocompatible assessments of components, materials and consumables used in the manufacture of products.
- Provides Technical Assessment for completion of Risk Assessments in the area of sterility and microbiology. Assessment and approval of acceptance of resolution to quality issues including concession management.
- Demonstrate technical supervisory capabilities and lead projects to completion.
Qualification Knowledge Skills
- Minimum Bachelor degree Microbiology or equivalent/ related subject required, with proven Microbiology related experience
- Proven experience in Quality/Regulatory Affairs environment.
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
- Lead auditor certification desirable.
- Thorough knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise (Microbiology)
- Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
- Knowledge of trends in industry and reg standards.
- Competent in presenting problems and their solutions.
- Good financial acumen.
- Strong Project management.
- Experience in leadership/management of people.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
Consultant | Engineering Recruitment
353 (0) 21 2300300