Job Title: Microbiologist Job Description This role is for a microbiologist who applies microbiological principles to the manufacturing of medical devices. The individual will be responsible for developing and maintaining process monitoring systems and metrics to ensure the microbiological integrity of the final product. The company is currently in the process of outsourcing manufacturing from on-site to third-party manufacturers. Responsibilities + Lead qualifications and documentation for controlled access environments, including specifications and disturbance reports. + Define gowning protocols and oversee water and compressed air system qualifications. + Provide guidance on cleaning procedures and chemical usage. + Offer technical support for environmental monitoring and microbiological methods. + Evaluate the microbial impact of changes in manufacturing processes. + Establish sterilization parameters based on device and packaging design. + Troubleshoot issues in routine and validation sterilization cycles. + Conduct annual validations for ethylene oxide and steam sterilization per regulatory standards. + Perform sterilization assessments for changes in process, packaging, load configuration, and design. + Apply mathematical calculations for sterilization (e.g., lethality, D-value). + Ensure compliance with reusable device regulations. + Develop and validate microbiological test methods. + Train lab technicians and review routine test reports. + Identify and communicate opportunities, risks, and solutions across teams. + Mentor microbiology staff and provide technical expertise. + Investigate calibration discrepancies and out-of-tolerance conditions. + Stay current with applicable standards and apply them to qualifications and testing. + Author protocols and reports for controlled access environments, compressed air and water systems, microbiological test methods, sterilization validations, and product adoptions. + Write procedures for lab operations, product monitoring, and component specifications. + Review and release sterile product loads. + Support supplier change notifications and review FMEAs. + Approve nonconforming material reports. + Serve as a subject matter expert during supplier and internal/external audits. + Participate in R&D and Operations project teams. + Support other initiatives as directed by the department. Essential Skills + Bachelor's Degree in Microbiology or a related scientific field, or an equivalent combination of education and relevant work experience. + Master’s Degree in Microbiology, Medical Device, Pharmaceutical Sciences, or a related industry field, with hands-on experience in microbiology, sterilization, and microbiological lab practices. + Minimum 7 years of experience in the medical device, pharmaceutical, or related industry, with a strong background in microbiology, sterilization processes, and microbiological laboratory work. + Minimum 3 years of experience with a Master’s degree in the same industries and disciplines. Additional Skills & Qualifications + EO sterilization validation experience (ideally in medical device). + Proven ability to articulate complex technical concepts clearly. + Demonstrated troubleshooting skills in advanced scenarios, such as sterilization or contamination issues, beyond routine out-of-specification cases. + Experience working within a cross-divisional or enterprise-wide business model. + Comfortable operating in a highly matrixed and geographically diverse environment. + Strong team collaboration and individual contribution skills in fast-paced, dynamic settings. + Ability to engage and leverage others to drive project success. + Excellent verbal and written communication skills, with the ability to communicate effectively across multiple organizational levels. + Skilled in multitasking, prioritization, and meeting deadlines. + Strong organizational habits, attention to detail, and follow-through. + Professional demeanor with minimal supervision required and consistent, reliable attendance. + Willingness and ability to travel approximately 5–25%, including internationally. Work Environment This is a 12-month contract role requiring a solid understanding of medical device manufacturing in cleanroom environments. While the role is desk-based and not lab-focused, it involves technical writing and cross-functional collaboration. The majority of the work is conducted on-site in Plymouth, supporting the electrophysiology business unit. Pay and Benefits The pay range for this position is $40.00 - $55.00/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 27, 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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.