STERILITY ASSURANCE STEWARD – TECHNICAL MANUFACTURING SCIENCE 3196737

Full-Time Onsite with Paid Relocation

Our Award Winning Client, recognized with numerous accolades, is in search of a Sterility Assurance Steward– Technical Services / Manufacturing Science (TS/MS) to join their dynamic team. This captivating role is based at the cutting-edge Parenteral, Device Assembly, and Packaging Facility in Research Triangle Park (RTP), North Carolina. As a key contributor, you will provide technical leadership across various facets of sterility assurance for parenteral products, actively shaping the facility’s design and operations.

Key Objectives / Deliverables:

  • Innovate and implement continuous improvement initiatives within sterility assurance programs.
  • Provide crucial design input for new processes at the RTP site.
  • Advocate and safeguard the site’s sterility assurance programs during both internal audits and external regulatory inspections.
  • Assist in the preparation of regulatory submissions related to sterility assurance programs.
  • Conduct comprehensive sterility assurance training for new hires and personnel across various sites.
  • Extend technical mentorship to less senior scientists and cross-functional personnel.
  • Stay current with external regulatory requirements tied to sterility assurance programs, actively contributing to corporate guidance revisions.
  • Develop and implement monitoring strategies, concentrating on areas of heightened microbial risk, encompassing disinfectant/sanitizing agent evaluation, airflow pattern testing, and aseptic process simulations.
  • Take the lead on major deviations, conducting root cause analyses associated with sterility assurance programs.
  • Leverage sterility assurance risk management to assess and elevate existing and proposed manufacturing processes.
  • Apply scientific principles to comprehend and enhance manufacturing processes for parenteral drug products.
  • Spearhead and engage in intricate projects linked to sterility assurance programs, ensuring alignment with HSE Corporate and Site Goals.

Minimum Requirements:

  • Hold a BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or a related scientific discipline.
  • Accumulate a minimum of 10 years’ experience in the biopharmaceutical industry.

Additional Preferences:

  • Possess a Master’s Degree in Microbiology, Biology, or a related field (preferred).
  • Demonstrate expertise in facility start-up and/or technical transfer, including proficiency in environmental monitoring performance qualification and aseptic process simulations.
  • Showcase prior experience in multiple functions associated with the manufacture of parenteral products.
  • Exhibit in-depth knowledge of risk management and adeptness in using risk assessment tools.
  • Showcase robust analytical and problem-solving skills.
  • Demonstrate excellence in technical writing and presentation skills.
  • Display effective teamwork and interpersonal skills coupled with the ability to influence.

Other Information:

  • Embrace a Monday through Friday role with flexibility to accommodate production schedules.
  • Be prepared for occasional extended hours and off-hour work.
  • The position is based at the RTP site, with intermittent travel to Indianapolis and other global company sites.

US Citizenship or Green Card Holders only apply

Note: Resumes will be maintained in strict confidentiality until such time as we engage in a detailed discussion regarding a specific opportunity, and both parties mutually agree to proceed. We consistently receive new opportunities every day. Should your professional background closely align with the specific requirements of our client, we will promptly reach out to you to initiate further exploration of potential opportunities.

Job Type: Full Time
Job Location: Durham
Date Posted: 02/26/2024

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