Scientist - TS/MS - Sterility Assurance Technology

Role Summary

Scientist - TS/MS - Sterility Assurance Technology. The Scientist positions in the Technical Services / Manufacturing Sciences – Sterility Assurance Technology (TS / MS – SAT) group provide support for control of the site’s manufacturing facilities, developing and implementing sterility assurance initiatives and providing technical leadership on sterility strategies.

Responsibilities

• Ensure site‚Äôs Environmental Monitoring, Aseptic Process Simulations, Facility Cleaning, Facility Sanitization, Sterility Assurance Risk Management, and other sterility assurance programs are followed at the manufacturing flow level.
• Provide technical guidance to the Flow and Process Teams for sterility assurance programs.
• Create and evaluate reviews of annual environmental monitoring data in addition to other sterility assurance periodic reviews.
• Lead or provide technical support for root cause investigations for sterility assurance programs.
• Use sterility assurance risk management to evaluate existing and proposed manufacturing processes and controls to prevent microbial, endotoxin, and particulate contamination.
• Execute and assist in developing process and facility monitoring strategies focusing on areas of highest microbial risk.
• Lead site aseptic self-inspection program including communicating observations and recommendations for continuous improvement to manufacturing and support personnel.
• Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
• Create, execute, review and/or approve technical documents related to sterility assurance programs including risk assessments, justification documents, protocols, and summary reports.
• Create, execute and/or review change controls related to sterility assurance programs.
• Continually educate self and others to drive improvements and stay current with regulatory expectations and industry trends.
• Participate in continuous improvement projects to improve site quality performance.
• Participate or provide guidance for sterility assurance programs during regulatory audits.
• Provide content and/or data integrity reviews for regulatory submissions.
• Lead training courses related to sterility assurance programs.

Qualifications

• Bachelor‚Äôs degree in Microbiology, Biology, or other STEM-related discipline with relevant experience.

Skills

• Maintaining a safe work environment and supporting HSE goals.
• Understanding of GMPs and internal standards.
• Parenteral Manufacturing experience.
• Strong oral and written communication; technical writing skills.
• Teamwork and interpersonal skills.
• Data trending and analysis experience.
• Analytical and problem-solving abilities.
• Quality orientation; ability to influence others.

Education

• None beyond the Bachelor‚Äôs degree specified in Qualifications.

Additional Requirements

• 8-hour days, Monday through Friday; overtime may be required.
• Dynamic and fast-paced environment; 5‚Äì10% travel required.
• Work in various areas within the Parenteral Site; some allergens present.
• Aseptic certification and entry into aseptic manufacturing areas; mobility considerations due to position.
• On-call support may be required.