Senior Staff Microbiologist
Location: Stryker, Limerick, Ireland.
Hybrid, 23-month fixed term contract. Not lab based.
Responsibilities
* Oversight of environmental & utility monitoring, bioburden and endotoxin testing practices and procedures, creating alignment and standardization across multi sites.
* Execution, review and approval of Gamma and Ethylene Oxide sterilization validations and re-qualifications in line with relevant BS EN ISO standards. Assessment of sterility supplier validation.
* 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 / sites. Strong competency in assessment of effectivity and resulting sterility compliance. Review and approval of CAPA.
* Act as technical lead for microbiology in cross functional groups including product and process issues, rootcausing, projects, initiatives and other business critical forums.
* Subject Matter Expert, audit and review of Supplier quality activities with critical vendors in 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).
* 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-siye / global 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. Input / BPO to corporate documents.
* Coach, mentor and train other functions in area of sterility and monitoring.
* 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 Stryker product.
* Provides Technical Assessment for completion of Risk Assessment for SofHA in area of sterility and microbiology. Assessment and approval of acceptance of resolution to quality issues including concession management.
* Demonstrate technical supervisory capabilities and leads projects to completion.
Qualifications and Knowledge
* Bachelor degree Microbiology or equivalent/ related subject required, with 6 years Microbiology related experience.
* Minimum of 8 years 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.
* 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 proficiency in statistal techniques, data review and analysis.
* High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
* Some travel may be required.
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Research, Analyst, and Information Technology
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
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