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Job: Sterility Assurance Manager, Thermo Fisher Scientific, Greenville, NC

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General Information

Job title:
Sterility Assurance Manager
Job location:
Greenville, NC  27834 United States
Requisition code:
Date posted:
Job category:
Quality Control
Employment type:
Full time

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information
Greenville, NC / Pharma Services Group

Apply today!

Job Requirements

How you will make an impact

Represent and be accountable for the site on the Sterile Working Group (potential future team leader) harmonizing practices across sites in the network to promote sterility assurance. Review & approve any Major/Critical deviation and any change proposals with Sterile Assurance impact (lead)

What you will do

Contamination control strategy (define/own/maintain for the site)
EM program (define/oversee/improve)
Media Fill Program (oversee)
Aseptic Comportment/Training/Oversight (Manage)
Sterilization processes (oversee)
Risk assessments and improvement programs (implement/manage - against current and future expectations)
Lead major investigations into issue impacting sterility Assurance (i.e. Adverse EM trends, media fill failures)
Staying up to date with best practice and sharing that knowledge (10% of time should be devoted to this)
Act as SME for the above with regulators / clients (i.e. key part of major audits)
Act as SME for new product introduction and for applicable capital projects (i.e. new lines/processes)
Implementing best practice (i.e. ensuring understanding / compliance with updated Annex 1 – owning the transition and any risk assessments we need)
Report status of and promote Sterility Assurance within the Senior Leadership Team (lead)
Audit other sterile sites and suppliers providing microbiological service or sterile materials (as required)
How you will get here

Relevant science-based degree; e.g. Microbiology, Applied Biology.
management qualifications (or equivalent experience).

Typically from a microbiology QC background, ideally within a sterile manufacturing site.
Substantial experience working in a pharmaceutical quality function, preferably within a sterile manufacturing site.
Has intimate knowledge of sterile processing at a supervisory/management level, ideally will have managed one or more sterile production lines.
Experience with validation of sterile processes would be advantageous
Involvement in capital projects (new build/refurbishment of sterile lines) would be advantageous
Intimate knowledge of Annex 1 and similar guidance
Leadership experience
Demonstrable audit/client facing experience.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today!
(Job number: 3875839)
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