Sterilization Specialist

Job Description

Job Description

Position Summary

We are seeking an experienced Sterility Assurance and Contamination Control leader to establish and enhance microbiological control strategies across a growing GMP manufacturing organization. This role will serve as the site subject matter expert (SME) for sterility assurance, contamination control, aseptic processing, and microbiological quality systems, supporting both clinical and commercial manufacturing operations.

The successful candidate will have extensive experience in sterile manufacturing environments, contamination control strategy (CCS) development, aseptic process simulation programs, environmental monitoring, and regulatory inspection readiness. This individual will play a critical role in ensuring compliance with EU GMP Annex 1, FDA Aseptic Processing Guidance, USP requirements, and global regulatory expectations, while supporting commercial launch readiness and manufacturing scale-up activities.

Key ResponsibilitiesSterility Assurance & Contamination Control

• Develop, author, and continuously improve site-wide Contamination Control Strategies (CCS) aligned with EU GMP Annex 1 and FDA aseptic processing guidance.
• Perform contamination risk assessments and drive associated remediation and continuous improvement initiatives.
• Establish and maintain inspection-ready sterility assurance programs across manufacturing operations.
• Serve as the site SME for microbiological control, aseptic processing, and contamination prevention strategies.
• Partner with Manufacturing, Quality, Regulatory Affairs, Validation, and Technical Operations to ensure a robust contamination control framework.

Aseptic Processing & Process Qualification

• Design, execute, and maintain media fill and aseptic process simulation programs.
• Lead smoke studies and airflow visualization assessments to support facility and process qualification.
• Develop strategies for sterilizing-grade filtration qualification, validation, and integrity testing.
• Oversee sterilization, depyrogenation, and aseptic process validation activities.
• Support process performance qualification (PPQ) and commercial manufacturing readiness efforts.

Environmental Monitoring & Microbiology Programs

• Develop and optimize environmental monitoring programs for classified manufacturing environments.
• Establish viable and non-viable monitoring strategies and trending programs.
• Lead microbial identification, data analysis, and contamination investigation activities.
• Perform trend analysis to identify emerging risks and drive preventive actions.
• Oversee microbiological control strategies for incoming materials, in-process testing, and final product release.

Rapid Microbiological Methods & Product Testing

• Support implementation, validation, and lifecycle management of rapid microbiological methods.
• Oversee endotoxin, sterility, bioburden, and mycoplasma testing strategies.
• Evaluate new technologies and testing platforms to improve efficiency while maintaining compliance.
• Ensure testing programs are scientifically justified and aligned with regulatory expectations.

Cleaning Validation & Disinfection Programs

• Support cleaning validation strategies for GMP manufacturing facilities and equipment.
• Develop and improve disinfectant qualification and effectiveness programs.
• Ensure microbial control measures remain effective throughout facility operations.

Regulatory Compliance & Inspection Readiness

• Author and review CMC sections supporting aseptic processing, microbiological controls, and sterility assurance programs.
• Lead pre-approval inspection (PAI) readiness activities.
• Serve as the primary sterility assurance SME during health authority inspections and customer audits.
• Support regulatory submissions, responses to agency questions, and ongoing compliance initiatives.
• Drive continuous improvement efforts to strengthen quality systems and inspection preparedness.

Required Qualifications

• Bachelor's degree in Microbiology, Biology, Biochemistry, Biotechnology, Pharmaceutical Sciences, or related life science discipline.
• 10+ years of experience in sterility assurance, microbiology, aseptic processing, or sterile pharmaceutical manufacturing.
• Demonstrated experience supporting biologics, cell therapy, gene therapy, or other sterile manufacturing operations.
• Extensive knowledge of contamination control strategies and microbiological quality systems.
• Hands-on experience leading media fill programs and aseptic process simulations.
• Strong understanding of EU GMP Annex 1 (2022), FDA Aseptic Processing Guidance, USP standards, and global GMP regulations.
• Experience leading contamination investigations, root cause analysis, and remediation efforts.
• Proven ability to work cross-functionally in a dynamic, regulated manufacturing environment.

Preferred Qualifications

• Experience supporting autologous cell therapy manufacturing operations.
• Experience with patient-specific manufacturing processes and associated contamination control challenges.
• Commercial launch readiness experience.
• Experience supporting organizations transitioning from clinical-stage manufacturing to commercial production.
• Experience supporting BLA, MAA, and Pre-Approval Inspections (PAIs).
• Experience implementing and validating rapid microbiological methods.
• Advanced degree (MS, PhD, or equivalent) preferred.

Key Competencies

• Sterility Assurance
• Contamination Control Strategy (CCS)
• Aseptic Processing
• EU GMP Annex 1
• Environmental Monitoring
• Media Fills & Process Simulations
• Smoke Studies & Airflow Visualization
• Sterilization & Depyrogenation Validation
• Rapid Microbiological Methods
• Endotoxin, Sterility, Bioburden & Mycoplasma Testing
• Cleaning Validation & Disinfectant Qualification
• Regulatory Inspections & Audit Readiness
• Cell & Gene Therapy Manufacturing
• Commercial Launch Readiness
• Clinical-to-Commercial Scale-Up

Why This Opportunity

This is a highly visible leadership opportunity to shape and mature the sterility assurance and contamination control programs for a cutting-edge cell therapy organization. The role offers significant influence over commercial readiness, regulatory compliance, and patient safety while supporting innovative therapies that are transforming healthcare.

Job Type & Location

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

Pay and Benefits

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)

Workplace Type

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

Application Deadline

This position is anticipated to close on Sep 28, 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.