Sr. Microbiologist (Sterilization) - iMPact Business Group
Cary, IL 60013
About the Job
Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Sr Microbiologist (Sterilization) for a 18 month + Contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
The Senior Microbiologist will be primarily responsible for the sterility compliance of product in accordance with relevant regulatory requirements and standards for medical devices. The senior microbiologist will oversee and ensure sustained levels of sterility compliance through testing, monitoring and validation of cleaning and sterilization processes and associated utilities.
POSITION REQUIREMENTS
POSITION REQUIREMENTS
Will work within the microbiology team, under general supervision, with responsibility to ensure effective and efficient sterility practices, which includes, but not limited to the following:
- Oversight of environmental monitoring of cleanrooms in line with ISO 14644 standards, and monitoring of utilities including all grades of water, and where necessary, compressed air, bioburden and endotoxin testing.
- Interpreting sampling and monitoring data, applying statistical and analysis techniques, to determine control and trending. Identifies and initiates when to take action.
- Leads NC and CAPA generation and resolution within the Microbiology group and across related business units. Strong competency in troubleshooting, correction of NC and root cause analysis.
- Act as technical lead for microbiology in cross functional groups including product and process issues, root causing, projects, initiatives and other business critical forums.
- Performing sampling for validations and re-qualifications as required. Review of validation files for compliance.
- Strong interactions, maintenance and support of sterility suppliers.
- Interact with Supplier quality team with respect to vendor sterility topics.
- Performs sterility release review, intepretaing data and trends.
- Performs sterilization validations and re-qualifications in line with relevant BS EN ISO standards.
- Continually identifies opportunity for stabilization of trends, statistical control of processes to allow cost saving.
- 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 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.
- Support of, ensure compliance of new products to sites" sterility standards. Ensure successful integration of products into validated processes.
- Ensures biocompatible of components, materials and consumables used in the manufacturing of product.
- Demonstrate technical supervisory capabilities and leads projects to completion
- Demonstrates knowledge of the business processes and products across multiples sites.
QUALIFICATION KNOWLEDGE SKILLS
- Minimum of 6 years in Quality/Regulatory Affairs environment.
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
- 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.
- 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 statistical techniques, data review and analysis.
- High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages
QUALIFICATION KNOWLEDGE SKILLS
- Minimum of 6 years in Quality/Regulatory Affairs environment.
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
- 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.
- 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 statistical techniques, data review and analysis.
- High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages
Source : iMPact Business Group
