Senior Associate, Sterility Assurance


Ames IA


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Job ID: EB-8664100521
Category: Consumer Products
Location: Ames, IA

Our client, a leader in their industry, has engaged our practice to place a Senior Sterility Assurance Associate. This exciting and newly created role will be based in the suburbs of Ames, Iowa and offers full relocation. This person will provide oversight to Sterility Assurance/Contamination Control Strategy deliverables of the manufacturing operations in the Biotech network, to guarantee that the production and analytical processes are carried out with appropriate Sterility Assurance standards, in alignment with Global procedures, GMP (Good Manufacturing Practices) and Regulatory expectations, as well as industry best practices. Author and develop functional procedures supporting Contamination Control, sterile and aseptic process/ cleaning, and disinfection validation plans for the site while working cross-functionally with process teams in production and TS/MS (Technical Services/Manufacturing Science) to improve and train the site Sterility Assurance related processes and programs (aseptic training/qualification, APS (Aseptic Process Simulation) program, EM (Environmental Monitoring) program, etc.). If you are looking to be a part of a strong and growing company, with global developmental opportunities to advance your career you’ll want to hear more about this great opportunity!


• B.S.in microbiology/biology or equivalent experience in lieu of degree
• 3+ years experience with sterile manufacturing and risk assessments and remediations implementation
• Familiarity with Global Regulatory Standards FDA (Food and Drug Administration), EU (European Union) GMP, USDA (United States Department of Agriculture), CFIA (Canadian Food Inspection Agency), as applicable
• Experience with a variety of technologies and platforms is preferred including poultry vaccine technologies, recombinant protein platforms, protein-based therapeutics, cell culture and fermentation technology

BrainWorks is a premier executive search firm that delivers superior talent to drive business performance. Our consultants are experts in their practice areas, which include Consumer Products Careers; CRM, Direct/Database Marketing and Customer Sciences/Advanced Analytics; Accounting and Finance; Information Technology; Private Equity & Corporate Finance Digital Marketing and eCommerce; and Consumer Insights and Market Research.

The Consumer Products Practice Group places top performing candidates from mid to senior-level executives with companies spanning from Fortune 10 to midsize regional and national firms. Our consumer products recruiters have extensive knowledge of current trends and industry challenges. Some examples of Consumer Products Executive Searches would include C-level Officers, VP’s, Directors and Senior Managers in the areas of Sales, Marketing, Product Development, and Operations.

BrainWorks prides itself on quality, speed and GUARANTEED RESULTS, delivered through our unique QUASAR approach. When you partner with BrainWorks, your company will receive intelligence and industry expertise from consultants who are trustworthy, caring and passionate about your business needs. https://brainworksinc.com.


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