Actalent
Expert Microbiologist - Medical Device Company
Offers Benefits | Excellent Opportunity for Growth | Day Shift: Mon-Fri from 8am - 4:30pm 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. 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, equipment qualifications, and LAL sampling analysis. 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. Qualifications:
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, strong in microbiology, sterilization processes, and microbiological laboratory work. Minimum 3 years of experience with a Master's degree in the same industries and disciplines. 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 Minneapolis, MN. Application Deadline
This position is anticipated to close on Aug 26, 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 for other accommodation options.
Offers Benefits | Excellent Opportunity for Growth | Day Shift: Mon-Fri from 8am - 4:30pm 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. 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, equipment qualifications, and LAL sampling analysis. 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. Qualifications:
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, strong in microbiology, sterilization processes, and microbiological laboratory work. Minimum 3 years of experience with a Master's degree in the same industries and disciplines. 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 Minneapolis, MN. Application Deadline
This position is anticipated to close on Aug 26, 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 for other accommodation options.