Sterility Assurance Program Manager

What you'd do

• Own and manage the sterility assurance program, including policies, procedures, and related documentation.
• Develop, implement, and maintain sterility assurance programs including sterilization validations, bioburden testing, endotoxin testing, and contamination control strategies.
• Lead cross-functional teams to assess sterility risks and develop mitigation plans.
• Oversee validation and monitoring of sterilization processes including aseptic processing, sterilizer cycles, and environmental controls.
• Own the planning, execution, and approval of aseptic process simulations (media fills) ensuring compliance with regulatory requirements and internal standards.
• Complete aseptic process validations, including protocol development, execution, data review, and final report generation.
• Ensure qualification and ongoing training of manufacturing personnel in aseptic techniques, contamination control, and sterility requirements.
• Prepare detailed technical reports and documentation related to sterility assurance activities for internal review and regulatory submissions.
• Ensure compliance with applicable regulations and standards (e.g., FDA, EMA, USP, ISO), with specific knowledge and application of EU GMP Annex 1 guidelines.
• Collaborate with Quality Assurance, Manufacturing, Microbiology, and Engineering departments to drive continuous improvement initiatives.

What they want

• Strong knowledge of aseptic processing, sterilization methods, contamination control, microbiological testing, aseptic process simulations (media fills), and process validations.
• Proven experience in the qualification and training of manufacturing personnel in aseptic techniques and sterility assurance requirements.
• Experience owning, executing, and reporting on aseptic process validations in compliance with regulatory standards.
• In-depth knowledge of EU GMP Annex 1 and the ability to apply its requirements effectively in a manufacturing environment.
• Familiarity with regulatory requirements including FDA cGMP, EMA, USP <71>, ISO 13485, and related standards.
• Experience with risk management methodologies and tools (e.g., FMEA, HACCP).
• Proven experience in managing sterility assurance programs and leading cross-functional initiatives.
• Excellent analytical, problem-solving, and project management skills.
• Strong communication and interpersonal skills.
• Ability to influence and drive changes in a complex, regulated environment.

What you get

• We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
• We invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
• We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
• We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
• We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.
• We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.