Senior Manager, Contamination Control and Sterility Assurance, RFM, QARA

Location: On-site at a Cytiva manufacturing site in the United States, including Pensacola, FL; Hauppauge, NY; Westborough, MA; or Duncan, SC. Travel of approximately 20–30%, including domestic and international travel.

Annual salary: $110,000–$125,000 USD, plus eligibility for bonus or incentive pay.

Company

hirify.global’s operating company Cytiva develops solutions for biological research, vaccines, medicines, and cell and gene therapies.

What you will do

• Lead contamination control and sterility assurance programs across multiple manufacturing sites.
• Implement and continuously improve contamination control strategies, microbial control programs, environmental monitoring, and sterility assurance practices.
• Provide technical expertise in contamination control, sterilization, aseptic processing, microbial control, and environmental monitoring.
• Support regulatory inspections, customer audits, internal quality assessments, investigations, root cause analysis, CAPA, and quality risk assessments.
• Establish metrics, trend analysis, risk management, and best-practice deployment across the manufacturing network.
• Connect global CCSA strategy with site execution through standardization and knowledge sharing.

Requirements

• Bachelor’s degree in Microbiology, Biology, Pharmaceutical Sciences, Engineering, or a related scientific discipline.
• 10+ years of experience in pharmaceutical, biotechnology, medical device, or other regulated life sciences manufacturing environments.
• Expertise in contamination control, sterility assurance, aseptic processing, microbial control, environmental monitoring, contamination control strategy development, and contamination risk management.
• Experience with regulatory inspections, customer audits, investigations, CAPA programs, quality risk management, and regulated quality systems.
• Experience leading technical teams, projects, or cross-functional initiatives in global, multi-site environments.
• Ability to work on site at a U.S. Cytiva manufacturing location and travel approximately 20–30%.

Nice to have

• Master’s degree in a relevant scientific or engineering discipline.
• Experience developing contamination control and sterility assurance programs across global manufacturing networks.
• Expertise in terminal sterilization, sterilization validation, ISO 11137, ISO 11737, contamination control strategy principles, and environmental monitoring governance.

Culture & Benefits

• Continuous improvement culture based on the hirify.global Business System.
• Medical, dental, and vision insurance for eligible employees.
• Paid time off and 401(k) benefits for eligible employees.
• Opportunity to support products and processes connected to patient safety and life sciences innovation.