Senior Microbiologist

Stryker

Cork, Ireland

Position Summary

The Senior Microbiologist will be primarily responsible for the biocompatibility, microbiological and sterility compliance of Strykers product in accordance with relevant regulatory requirements and standards for medical devices. The microbiologist will oversee and ensure sustained levels of compliance through scientific evaluations, testing, monitoring and validation of materials, manufacturing and sterilisation processes.

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 2 or more years experience.

Position Requirements

The Sr. Microbiologist will be responsible for the Biosafety (Biocompatibility, Sterilisation and Microbiology) activities and will be a subject matter expert for the Division and manufacturing. This role will coordinate biosafety activities and ensure process is compliant to standards and regulations and will execute quality initiatives that support compliance to standards as well as identifying opportunities for improving the biosafety processes at the Divisional and manufacturing level. The Sr. Microbiologist will be responsible for the following when applicable (not an exclusive list):

Perform microbiology, sterilization, biocompatibility, and chemical assessments and evaluations for new product introduction, design changes, and process changes/improvements;
Co-ordination of samples for chemical, biocompatibility, microbiological, and sterility testing or assessment;
Strong interactions, maintenance and support of biocompatibility, microbiological, and sterility vendors;
Interact with Supplier quality team with respect to vendor biocompatibility, microbiological, and sterility topics;
Interpreting data, applies statistical and analysis techniques where applicable, to determine control and trending;
Leads NC and CAPA generation and resolution within the Quality Sciences group and across related business units. Strong competency in troubleshooting, correction of NC and root cause analysis;
Performs sterilisation validations and re-qualifications in line with relevant standards and regulations;
Mentors and trains team and cross functional groups as required (induction, GMP etc.);
Subject matter expert to internal & external regulatory requirements, (including but not limited to European RHQ, Division, Corporate, FDA, ISO, MDD/MDR, and individual country regulatory requirements);
Subject matter expert to divisional and local 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;
Ensures biocompatible of components, materials and consumables used in the manufacture of Stryker product.

Qualification Knowledge Skills

Bachelor degree/Masters of Microbiology or equivalent; and
2 years minimum experience as a Microbiologist (LAL/Bioburden/EM testing, Biocompatibility, Sterilization);
4 years of experience as a Microbiologist (LAL/Bioburden/EM testing, Biocompatibility, Sterilization) is preferred, Master’s Degree preferred;
Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously;
Strong interpersonal skills;
Strong written and oral communication and negotiations skills;
Strong in critical thinking and "outside the box" thinking;
Highly developed problem solving skills;
Strong analytical skills;
Demonstrated ability to successfully manage and complete projects in a matrix organization;
Demonstrated ability to work independently;
Experience in working in a compliance risk situation;
High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages;
Some travel may be required.