Senior Scientist
Location:
Plymouth , Minnesota
Posted:
April 02, 2017
Reference:
5776170322-en-us

"Caring for the world… one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored by the Credo. Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.

The Senior Sterility Assurance Scientist will be responsible for simultaneously working on multiple initiatives in support of business/technical objectives in microbiology, cleaning and sterilization to support the reprocessing of medical devices.  The candidate will be a key contact advising teams on specific cleaning and sterilization validation requirements, developing appropriate test methods and reviewing and approving product release records.  This position will require the candidate to work on projects of various sizes and complexities, coordinate with sterilization contractors and microbiology laboratories, determine appropriate product family groupings for complex product orientation, and troubleshoot any sterilization process deviations and microbiological excursions.  The candidate must have strong leadership and project management skills to coordinate routine sterilization validations and support ongoing operations at the contract manufacturer.

  • Assist the Director of Quality & Regulatory Affairs in meeting all departmental objectives
  • Responsible for delivering the sterility assurance in all aspects of the Quality System
  • To review and develop protocols/procedures related to all product sterility assurance activities
  • Assist the Director of Quality & Regulatory Affairs to manage the regulatory compliance program
  • Work with contract manufactures to ensure proper microbiological facility control including the validation of DI Water Systems, controlled environments and cleaning system validations
  • Partner with contract manufactures to implement the appropriate GMP training program for controlled environments
  • Lead Sterility Assurance on process assessments for existing products & new product development
  • Assist the Director of Quality & Regulatory Affairs in meeting all departmental objectives
  • Responsible for delivering the sterility assurance in all aspects of the Quality System
  • To review and develop protocols/procedures related to all product sterility assurance activities
  • Assist the Director of Quality & Regulatory Affairs to manage the regulatory compliance program
  • Work with contract manufactures to ensure proper microbiological facility control including the validation of DI Water Systems, controlled environments and cleaning system validations
  • Partner with contract manufactures to implement the appropriate GMP training program for controlled environments
  • Lead Sterility Assurance on process assessments for existing products & new product development
  • Ensure Cleaning and Sterilization validations are completed for all SterilMed products, including annual re-qualifications, NPRT studies, etc
  • Work with testing laboratories to help ensure performance of appropriate protocols, sample delivery, as well as coordination of results into written test reports.
  • To ensure regular microbial monitoring of all manufacturing facilities and water systems, to analyze the results and recommend corrective action where appropriate
  • To oversee Sterility Assurance program for SterilMed and partner with the greater Sterility Assurance Community and drive product compliance to AAMI/ISO regulation requirements
  • Ensure effective and timely communications both oral and written (weekly/monthly written reports, Project updates,)
  • To lead specific projects as allocated by the Senior Director of Sterility Assurance
  • Work with counterparts contract manufactures, sterilization providers and contract laboratories to develop and implement harmonized product specific procedures and methods
  • Lead trouble shooting for product/process non-conformances OOS test results, failure investigations, and providing resolution to issues via robust CAPA
  • Working in conjunction with NPD, document and maintain in good order all relevant Sterility Assurance sections of Device History File (DHF)
  • Coordinate acquisition of sample devices and other related activities as is required for verification and validation testing of potential new devices
  • Ensure compliance with all Documented Quality system, FDA QSR’s and ISO requirements
  • Actively support all defined site goals and objectives
  • All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform and are committed to building a positive work culture

 


Qualifications
  • A minimum of a Bachelor’s degree in Microbiology, Biology, Engineering, Physics or closely related discipline is required.
  • A minimum of 5 years related experience is required.
  • An advanced degree preferred.
  • Hands on experience in sterilization, microbiology, engineering, R&D or related field required.
  • A detailed knowledge of AAMI/ISO standards requirements for medical device reprocessing and sterilization is preferred.
  • Strong understanding of reusable medical device reprocessing, cleaning and sterilization validations is a requirement.   
  • Candidates must have demonstrated capability to conduct tests and studies under minimal supervision.
 


The Senior Sterility Assurance Scientist must have experience and demonstrate a strong working knowledge in:

  • AAMI/ISO Ethylene Oxide Sterilization Validations;
  • Temperature and Relative Humidity Studies;
  • AAMI/ISO Biocompatibility, including EO residuals;
  • Applicable industrial Microbiology procedures related to sterilization process validations and routine monitoring, including knowledge in Endotoxin testing requirements;
  • AAMI/ISO Reusable Device Cleaning Validations;
  • Environmental monitoring for viable, non-viable particulates, water systems and compressed air;
  • Prior experience in the medical device industry is preferred
  • Proficient in Microsoft Office
  • Experience working with MS Visio and Project
  • Ability to function independently as well as part of a team
  • Ability to manage multiple priorities in fast-paced environment
  • Strong attention to detail and organizational skills
  • Ability to work effectively and respectfully with associates at all levels
 

The candidate must demonstrate a proven track record of innovative thinking which has translated into business opportunities, recognizing and acting on new opportunities. The successful candidate will exhibit the ability of being a visionary thinker into the short and long term future identifying new opportunities or threats and the ability to prepare the organization for a proactive position to address industry and/or regulatory change. The candidate will possess excellent written and verbal communication skills used to influence and challenge the status quo.   





Primary Location
United States-Minnesota-Plymouth
Organization
Sterilmed, Inc. (6215)
Job Function
R&D
Requisition ID
5776170322

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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