Staff Microbiologist en Mahwah, NJ a Stryker Corporation

Fecha de publicación: 6/13/2019

Resumen de la oferta

Descripción del empleo

Who we want

  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.
  • Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

This is an opportunity to work as a sterility expert supporting new product development and supporting any changes to medical devices currently on the market. The role will have a balance of microbiology lab work, in addition to participation in cross functional teams.

  • Apply cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of orthopedic implants and surgical instruments.
  • Participate in the development and improvement of the manufacturing processes for existing and new products.
  • May lead in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ).
  • Be the point of contact for suppliers for new process development, quality issues and process improvements for assigned projects.
  • Support product transfers to other plants/facilities.  
  • Review/approve nonconforming material and system documentation. 
  • Review/approve product and process change control documentation and specifications.

What you need

  • Bachelor’s Degree in Biology, Microbiology, or a closely related life science.
  • 5 + years of applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.
  • Must understand the fundamentals of at least one of the following sterilization techniques: gamma irradiation, ethylene oxide (preferred), hydrogen peroxide gas plasma, moist heat, or dry heat and be an expert in one of the techniques.
  • Must be results oriented, a quick learner, team player and able to respond to the urgent needs of the team ensuring all deadlines are met.
  • Travel 5% - 10%

Work From Home: No

Travel Percentage: None

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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