CON Sterility Assurance Scientist

Sterility Assurance Scientist
Concord, NC
On-Site Role
6 Month Contract (potential for extension)

Our client is seeking a Sterility Assurance Scientist for a 6-month contract in Concord, NC, with potential for extension. This technical role is responsible for developing and implementing the site’s sterility assurance programs and contamination control strategies, providing technical guidance and expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies, including disinfectant efficacy. The position offers technical leadership for the Parenteral Process Team and mentorship within the TSMS team, engaging in both site-specific and external activities to establish robust contamination control strategies.

The role involves oversight of sterility assurance programs at the manufacturing floor level, authoring and executing performance qualifications, analyzing microbial and manufacturing data, supporting root cause investigations, and participating in audits. The Sterility Assurance Scientist will work cross-functionally to implement objectives and deliver on business and quality goals. Flexibility is required to support production schedules, including occasional extended hours, off‑hour work, and travel for training and implementation.

The position may require repetitive motion, standing or walking for long periods, and working in cleanroom environments with appropriate PPE.

• Develop and implement sterility assurance programs and contamination control strategies for the site
• Provide technical guidance and oversight for environmental monitoring, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization activities, including disinfectant efficacy
• Lead or support technical activities related to airflow pattern testing, environmental monitoring performance qualifications (EM PQ), aseptic processing techniques, and facility monitoring
• Author, execute, review, and approve technical documents, protocols, and change controls related to sterility assurance programs
• Analyze microbial and manufacturing data to identify trends, process discrepancies, and opportunities for continuous improvement
• Apply sterility assurance risk management to evaluate manufacturing processes and associated controls for potential microbial, endotoxin, and particulate contamination
• Lead or support root cause investigations and corrective actions for sterility assurance issues
• Participate in and provide technical support during internal and external audits
• Mentor team members and collaborate with cross-functional teams to achieve business and quality objectives
• Support the development and maintenance of cleanroom gowning and aseptic technique strategies/programs
• Assist with identifying facility environmental isolates and maintaining environmental isolated cultures
• Author and oversee execution of APS protocols, evaluate APS data, and ensure regulatory requirements and global quality standards are met for each manufacturing line/process
• Adapt to changing project and production schedules, including occasional extended or off‑hour work and travel as needed
• Perform tasks that may require repetitive motion, standing or walking for long periods, and wearing appropriate PPE and cleanroom attire

• Bachelor’s or master’s degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
• Demonstrated understanding and experience with scientific principles for manufacturing parenteral drug products under cGMP conditions, including operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance
• 2+ years (Senior) or 5+ years (Principal) pharmaceutical manufacturing experience in Microbiology, Sterility Assurance, TSMS, or related departments
• Technical expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, cleaning/sanitization strategies, and disinfectant efficacy
• Knowledge of microbiological media, enumeration…