Sr Microbiologist
Medical Device
Minneapolis, MN
Microbiologist Quality Assurance
Minneapolis, Minnesota
Quality & Regulatory Affairs
Experience: 3-5 years
Position Description Support new product introduction, maintain sterility assurance of sterile devices and regulatory compliance by developing, validating and documenting sterilization processes. Assist the Quality Systems Manager (QSM) to develop corporate sterilization and biological safety testing policies and procedures for laboratory and cleanroom area and provide training to all company personnel involved with these processes. Supports other company sites as their company microbiologist. Supervises the microbiology laboratory (micro. lab.). Applies standard engineering and microbiological practices and techniques to specific situations, adjusts and correlates data, recognizes discrepancies in results, and follows operations through a series of related detailed steps or processes. Performs biological safety evaluations of medical devices in accordance with ISO10993 Part 1. Develops and maintains a database for biological safety test reports and biological safety clearance request forms. Support QA Engineering with customer complaint investigations and new product development projects, which require expertise in microbiology and biological safety.
Requirements
1.Sterilization of Medical Devices – Ethylene Oxide and Irradiation
• Performs annual reviews of sterilization processes controlled by company or subcontract manufacturers and recommends any validation studies required to demonstrate continued compliance with internal procedures and regulatory requirements.
• Develop sterilization validation studies and write the protocols before the validation study commences. This includes protocols for microbiological, physical, process residues, shelf life and product & packaging functionality aspects of sterilization validation.
• Implement and maintain procedures for the control of sterilization clearance approval of new products or design/process changes.
• Prepare new product introduction or design change sterilization clearance requests for approval..
• Write validation reports and have them approved before the sterilization process or change is implemented.
• All protocols and validation reports shall be reviewed and approved before they are implemented.
• Where required assist the department manager with auditing subcontractors for sterilization.
• Designee for releasing goods as sterile.
• Develops and maintains databases for sterilization validation studies, sterilization releases and environmental data. Provide training to relevant personnel using the databases.
• Irradiation sterilization - Ensures that procedures for quarterly dose auditing are up to date and that the dose audits are performed on time.
• Develop, write, implement and maintain quality system procedures for validation and routine control of sterilization and other relevant processes.
• Coordinates and project manages validation runs at contract sterilizer, and testing required at contract test labs
• Review developing Standards, regulations and reports to the department manager any significant developments to ensure that company maintains compliance.
2. Manufacturing Environmental Control
• Develop, write, implement and maintain procedures for the environmental control of manufacturing areas and monitoring requirements to demonstrate continued compliance with regulatory and Standards requirements.
• Develop, write, and implement validation protocols for new or modified cleanrooms.
• Train microbiology technicians and other relevant personnel against the procedures and the testing techniques.
• Perform and annual review of the environmental and final product test limits. Also, review the test limits in light of any significant process changes.
3. Microbiology Laboratory Supervision
• Supervise the microbiology laboratory
• Ensure that work is correctly prioritized through communication with internal customers and the technicians,
• Ensure that activity deadlines are met or otherwise communicated with internal customers and supervising manager,
• Test results are reported and any corrective action required is implemented in accordance with internal procedures,
• Provide training to the technicians.
4. Microbiological Support for company
• Perform laboratory testing of environmental samples and final product testing for other company sites as directed by the department manager.
• Be prepared to travel to the other company sites to perform on site samples collection, testing and auditing.
• Be available to offer consultation to address site issues relating to microbiology for other company sites.
5. General
• Provide assistance to the department manager on any activity, which is reasonably within the scope of the incumbent’s skills as directed by the department manager.
• Provide a monthly management activity report to the department manager.
• Work with minimal supervision and communicated effectively to the department manager in a timely manner any conflicting priorities or activities exceeding agreed deadlines.
Minimum Education and Experience Bachelor's degree in Microbiology, Chemistry, Mechanical, Chemical or related engineering field, with at least 5 years professional level experience within the medical, or closely related industry required
Minimum Knowledge Abilities and Skills • Expert knowledge of FDA guidelines (GMP, GLP) ISO and international guidelines and standards for sterilization (EO, Irradiation, steam etc.), product testing, biological safety and process residues such as ethylene oxide.
• Knowledge of materials used to make finished product, and biocompatibility testing requirements needed to qualify these materials.
• Expert knowledge of cleanroom design, testing requirements and data; ability to analyze related data.
• Decision making ability to develop and document sterilization processes.
• Ability to develop and perform biological tests.
• Ability to accomplish work such as biological testing personally or through department staff.
• Knowledge of microbiology principles.
• Uses considerable judgment in the planning, scheduling and coordinating of project phases, as well as the selection of engineering techniques and criteria. Strong analytical and problem solving skills are required.
• Ability to exercise judgment in making preliminary selections and adaptations of engineering alternatives.
• Excellent verbal communication skills and technical writing skills. Able to plan and conduct effective meetings and group presentations.
• Knowledge and skill in engineering documentation procedures, development methods and project management, with the ability to rapidly master internal procedures and methods, such as Documentation System, ECOs, DOEs, DVTs, MDAs, etc, within established training guidelines and timetables.
• Depth of knowledge of SOPs, GMP/FDA/ISO 9001 standards and proven ability to integrate into reliability engineering discipline.
• Ability to work with engineering staff members, within and outside the unit, in an effective and positive manner.
• Knowledge of medical device manufacturing processes.
• Ability to supervise, motivate, and evaluate employee’s performance.
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