Sterility Assurance Specialist

Job Description

Job Description

Sr Manager, Sterility Assurance & MicrobiologyAbout the Role

We are seeking an experienced Sterility Assurance and Microbiology leader to drive contamination control, aseptic processing, and sterility assurance programs supporting advanced therapeutics manufacturing. This individual will serve as a key technical expert responsible for developing and maintaining contamination control strategies, supporting regulatory readiness, and ensuring compliance with global GMP expectations.

The ideal candidate brings deep expertise in sterile manufacturing environments, microbiological control, and regulatory inspection preparedness, with experience supporting biologics, cell therapy, gene therapy, or other aseptic manufacturing operations.

• Develop and maintain site-wide contamination control strategies to support aseptic manufacturing operations.
• Lead contamination risk assessments, mitigation activities, and continuous improvement initiatives.
• Design, implement, and maintain robust sterility assurance programs that support inspection readiness and regulatory compliance.
• Oversee aseptic process simulations, media fills, and process qualification activities.
• Lead airflow visualization studies and support facility and process design evaluations.
• Support sterilization validation, filtration strategies, and integrity testing programs.
• Develop and enhance environmental monitoring programs for manufacturing and controlled environments.
• Establish viable and non-viable monitoring strategies and ensure ongoing program effectiveness.
• Own gowning qualification programs and aseptic technique training initiatives.
• Lead contamination investigations, root cause analyses, microbial identification activities, and trend reporting.
• Develop microbiological control strategies for raw materials, in-process testing, environmental monitoring, and finished product release.
• Support implementation and validation of rapid microbiological methods and emerging technologies.
• Oversee testing programs including sterility, endotoxin, bioburden, and mycoplasma assessments.
• Partner with Quality, Manufacturing, Validation, and Regulatory teams to support cleaning validation and disinfectant qualification programs.
• Author and review regulatory submissions, technical reports, procedures, and control strategies supporting sterile manufacturing.
• Lead inspection readiness efforts and serve as the sterility assurance subject matter expert during regulatory inspections and customer audits.

• Bachelor's degree in Microbiology, Biology, Life Sciences, Biochemistry, Biotechnology, or a related scientific discipline.
• 10+ years of experience in sterility assurance, microbiology, contamination control, or aseptic manufacturing environments.
• Experience supporting biologics, cell therapy, gene therapy, vaccine, or sterile pharmaceutical manufacturing operations.
• Proven experience developing and owning contamination control and sterility assurance programs.
• Hands-on experience leading media fill programs, aseptic process simulations, and contamination investigations.
• Strong knowledge of GMP regulations, aseptic processing principles, environmental monitoring programs, and microbiological control systems.
• Experience supporting regulatory inspections, audit readiness activities, and health authority interactions.
• Excellent leadership, problem-solving, and cross-functional collaboration skills.

• Experience supporting commercial manufacturing and product launch activities.
• Experience in autologous or patient-specific cell therapy manufacturing.
• Experience supporting clinical-to-commercial manufacturing transitions and process scale-up initiatives.
• Experience validating rapid microbiological methods and implementing new technologies.
• Experience supporting regulatory submissions, including BLA, MAA, or pre-approval inspection activities.
• Expertise in sterile manufacturing facility design, qualification, and contamination control strategies.

• Sterility Assurance
• Microbiology
• Contamination Control
• Aseptic Processing
• GMP Manufacturing
• Environmental Monitoring
• Regulatory Compliance
• Media Fill Execution
• Root Cause Investigation
• Inspection Readiness
• Cell Therapy Manufacturing
• Gene Therapy Manufacturing

• Strong technical expertise in sterile manufacturing and contamination control.
• Ability to lead through influence and collaborate across multiple functional groups.
• A proactive, solutions-oriented approach to problem-solving and continuous improvement.
• Passion for advancing innovative therapies while maintaining the highest standards of product quality and patient safety.

Experience Level: Sr / Expert Level

If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com.

This is a Contract position based out of Winston-Salem, NC.

The pay range for this position is $75.00 - $85.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Winston-Salem,NC.

This position is anticipated to close on Sep 24, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.