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Senior Sterilization Scientist, Microbiological Quality and Sterility Assurance (MQSA)

Auris Health

Auris Health

Quality Assurance
Cincinnati, OH, USA
Posted on Thursday, June 29, 2023
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Description

Ethicon, Inc., part of the Johnson and Johnson family of companies, is recruiting for a Senior Sterilization Scientist , Microbiological Quality and Sterility Assurance (MQSA) located in Raritan, NJ or   Cincinnati, OH.

Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit  www.ethicon.com .

The Senior 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

Qualifications

Education:

·      Master’s Degree in Arts or Science in either Life Science, Engineering, or related scientific/technical discipline required (e.g., Biology, Microbiology, Physics, etc.) or equivalent related work experience, in lieu of a degree, is required.

Experience and Skills

Required:

  • 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)

Preferred:

  • Knowledge of Lean and Six Sigma
  • Ability to adapt to changing priorities
  • Project management skills

Other:

·        The anticipated base pay range for this position is $73,000 to $102,000. 

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.]