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Sterilization Specialist

Job Description

This role involves performing sterilization validation for both new and existing products using Ethylene Oxide (EO) and/or Radiation sterilization methods. The position requires expertise in conducting comparative resistance studies and EO/ECH residual testing, while supporting R&D teams with sterilization validations for new product development and design changes. The specialist will serve as a Subject Matter Expert (SME) on sterilization for cross-functional product development teams and evaluate Supplier Change Notifications for potential impacts on product bioburden, bacterial endotoxins, and sterilization efficacy. Writing Environmental Disturbance Reports (EDRs) related to changes in the manufacturing environment and investigating issues related to environmental monitoring, compressed air, bioburden, endotoxins, and sterilization are key components of this role.

Responsibilities

+ Perform sterilization validation for new and existing products using Ethylene Oxide (EO) and/or Radiation sterilization methods.

+ Conduct comparative resistance studies and EO/ECH residual testing.

+ Support R&D teams with sterilization validations for new product development and design changes.

+ Serve as a Subject Matter Expert (SME) on sterilization for cross-functional product development teams.

+ Evaluate Supplier Change Notifications for potential impacts on product bioburden, bacterial endotoxins, and sterilization efficacy.

+ Write Environmental Disturbance Reports (EDRs) related to changes in the manufacturing environment.

+ Investigate issues related to environmental monitoring, compressed air, bioburden, endotoxins, and sterilization.

+ Plan and manage complex project assignments, prioritize tasks, and maintain project timelines.

+ Select appropriate scientific methods and techniques to lead projects to completion.

Essential Skills

+ Strong knowledge of medical device manufacturing and sterilization processes.

+ Familiarity with cleanroom classifications (ISO 8 & 9) and cleanroom dynamics, including pressure differentials and particle counts.

+ Understanding of bioburden and endotoxin testing, and how environmental or product changes may impact these metrics.

+ Ability to assess and communicate risk to product sterility and regulatory compliance.

+ Excellent technical writing and documentation skills.

Additional Skills & Qualifications

+ Bachelor’s degree in Microbiology, Biology, or a related scientific field with 5 years of experience in the medical device or pharmaceutical industry OR 2 years of experience with a Master's Degree.

+ Experience working in or supporting cleanroom environments.

+ Confident communicator with the ability to work across cross-functional teams (e.g., Quality Engineering, Manufacturing, R&D, Regulatory).

+ Analytical mindset with the ability to interpret test results and understand their implications on product safety and compliance.

+ Comfortable engaging with diverse teams and stakeholders.

+ Able to work independently with minimal training.

+ Proactive and curious—interested in understanding the “why” behind test results and environmental trends.

Work Environment

The role is based on-site in Plymouth, requiring attendance five days a week. It is primarily desk-based, with close collaboration with the manufacturing floor. While not lab-focused, the position involves technical writing and collaboration with microbiologists working in the lab. Candidates must understand cleanroom classifications and be comfortable with cross-functional communication. The position is project-based and requires someone confident and analytical, with an understanding of the causes and implications of test results.

Pay and Benefits

The pay range for this position is $30.00 - $40.00/hr.

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 Plymouth,MN.

Application Deadline

This position is anticipated to close on Aug 6, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.