WHAT YOU NEED TO SUCCEED (MINIMUM QUALIFICATIONS):

• Education: B.S. in a related field (Microbiology, Biology, etc.) or equivalent experience in lieu of degree.
• Experience: A minimum of 3 years’ experience with sterile manufacturing.
• Top 2 skills: Familiarity with Global Regulatory Standards (FDA, EU GMP, USDA, CFIA) and experience with a variety of technologies and platforms (e.g., monoclonal antibodies, poultry vaccine technologies).

WHAT WILL GIVE YOU A COMPETITIVE EDGE (PREFERRED QUALIFICATIONS):

• Experience with upstream production of viruses in cell monolayers, bioreactors, and fermenters, or experience with biologicals manufacturing.
• Lean manufacturing and Six Sigma experience.
• Proven organization and time management skills to meet time-sensitive deadlines, with strong attention to detail and collaboration.
• Ability to work in a fast-paced, dynamic environment with changing priorities, and flexibility to support multiple projects simultaneously.

YOUR ROLE: STERILITY ASSURANCE CONSULTANT

As the Sterility Assurance Consultant, you will provide oversight and direct contributions to Sterility Assurance/Contamination Control Strategy deliverables within our Biotech network. Your primary goal is to ensure that production and analytical processes adhere to appropriate Sterility Assurance standards, aligning with Global procedures, GMP, regulatory expectations, and industry best practices.

YOUR RESPONSIBILITIES:

• Serve as the primary technical expert in contamination control, aseptic processing, and sterilization, providing guidance and support to manufacturing operations.
• Lead and oversee the validation and qualification of facilities, processes, equipment, and systems related to sterility assurance.
• Identify and troubleshoot issues, conduct root cause analyses, implement corrective actions, and drive continuous improvement initiatives.
• Develop and deliver comprehensive training programs on sterility assurance principles, best practices, and regulatory requirements.
• Ensure compliance with all applicable regulations and industry standards, support regulatory inspections and act as a subject matter expert during audits.