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Senior Sterilization Scientist MQSA - medical device - microbiology

Cincinnati, OH 45242

Posted: 08/22/2023 Employment Type: Direct Hire Industry: Biomedical Engineer Job Number: 20387 Pay Rate: $73,000 to $110,000

Job Description

Senior Microbiology Sterilization Scientist MQSA provides technical leadership within the Franchise R&D Quality sector. This position requires translation of product Microbiological Quality and Sterility Assurance (MQSA) quality requirements into product sterility and process improvements. The position requires an investigative approach by applying strong MQSA principles to deliver effective solutions to achieve regulatory requirements over a broad range of national and international standards. Responsible for root cause identification as well as implementation of improvements.  Accountable for leading the design and validation of terminal sterilization processes for new products manufactured globally both in-house and by external manufacturers.

Key Responsibilities:
  • Support the sterilization portion of the integration of new products or modifications to existing products into designated plants or external manufacturers.
  • ·Prepare sterilization strategies and provide technical leadership for product and/or process changes.
  • ·Prepare protocols and provide technical leadership for validation/revalidation of radiation, dry heat, moist heat, and ethylene oxide sterilization processes for designated internal and external sterilizers.
  • Advise teams on microbiological issues related to product design.
  • Advise development teams & operations on sterilization validation requirements, appropriate test methods & manufacturing environment to meet quality, cost & release to market objectives. 
  • Support Base Business Sterilization goals and objectives for harmonization of validation, revalidation and testing processes across franchise.
  •  Trouble-shoot sterilization process deviations and develop short & long-term solutions to prevent reoccurrence with possible assistance of more senior level associates.
  • Advise QS, RA & Product Inquiry on specific sterilization / microbiology questions.
  • Ensure any contractors can meet sterilization policy requirements. 
  • Manage projects of various size & complexity, but complex projects with high impact to organization will be primary focus.
  • Perform technical assessments of contract companies related to sterilization & microbiological functions.
  • Evaluate sterilization related processes.
  • Set direction for sterilization validation testing.
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Provides sterilization support for internal and external audits.
  • Strong written & verbal communication skills
·      Master’s Degree in Arts or Science in either Life Science, Engineering, or related scientific/technical discipline required (e.g., Biology, Microbiology, Physics, etc.)

Experience and Skills
  • A minimum of four years of direct experience with medical device and/or diagnostic sterilization processes is required with experience at the Scientist/Engineer level or equivalent external experience
  • Demonstrated proficiency in medical device sterilization
  • Working knowledge of terminal sterilization technologies including radiation, ethylene oxide and moist heat
  • Sufficient experience & training in radiation sterilization, ethylene oxide sterilization & microbiology laboratory procedures to independently resolve sterilization process issues & coordinate appropriate testing
  • Maintains working knowledge of relevant standards and compendial methods for sterilization and sterility assurance (e.g., AAMI, ISO, ASTM, USP/EP/JP, etc.).
  • Knowledge and experience in national/international standards in quality management, sterilization methods, microbiological quality and sterility assurance is required.  Knowledge of regulatory requirements
  • Experience in leading multi-functional project teams for the design and validation of sterilization processes for medical products
  • Knowledge Microsoft Office (word processing, project planning, presentation, e-mail, flow charts & spreadsheet software)
  • Knowledge of Lean and Six Sigma
  • Ability to adapt to changing priorities
  • Project management skills

Meet Your Recruiter

Sean Goulding
Vice President – Technical Recruiting, Skilled Labor, Accounting And Finance

Sean has over 8 years’ experience with Mattson Resources and over 20 years in executive search, technical recruiting, and staffing. With a Bachelor’s in Business Administration and a concentration in Human Resources as well as 16 years agency experience and 4 years corporate in staffing – Sean and his team can assist in all areas of search for your hiring needs. In agency search, Sean has led teams and recruiting services for Engineering, Sciences, IT, Skilled Labor, Operations, Supply Chain, Operational Excellence and more for Medical Device, Pharma, Aerospace, Automotive, Distribution, Transportation, IT Services, Software, Food & Beverage, Retail, and Consumer Products. In 2021 Sean oversaw Mattson Resources expansion and opening of a satellite office in Corona, CA.

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