Sr Sterilization Microbiologist

Senior Microbiologist Sterilization and Quality Systems

Hybrid Schedule | Long-term Growth | Offers Benefits Job Description This Senior Microbiologist role provides technical leadership and oversight for sterilization department objectives and corporate microbiology and sterilization strategies across a regulated manufacturing environment. You will serve as a microbiology subject matter expert, partnering closely with Manufacturing, Quality, Supplier Quality, Regulatory Affairs, Research & Development, and external business partners to evaluate microbiological risks, support investigations, guide product and process changes, and ensure alignment with applicable quality system requirements. Operating in a highly collaborative setting, you will use scientific expertise and risk-based decision making to support product quality, patient safety, and regulatory compliance for existing and new products, including contract manufactured devices and acquisition-related activities. Responsibilities

- Manage assigned Sterilization Department projects, ensuring effective planning, execution, and documentation in support of product quality and regulatory compliance.
- Review regulatory documentation for design dossier submissions and Pre-Market Approval submissions, ensuring sterilization strategies and microbiological controls are appropriately justified and clearly presented.
- Develop and author sterilization-related responses to questions posed by regulatory bodies and notified organizations, providing clear scientific rationale and risk-based explanations.
- Set direction for activities that minimize regulatory exposure related to product sterilization during development and manufacturing, and actively participate in regulatory groups to ensure sterilization requirements are accurately conveyed.
- Consolidate and analyze questions received from regulatory agents across manufacturing sites, and translate these into corporate guidance that informs the writing of design dossiers and pre-market approvals.
- Act as a corporate resource for sterilization services, reviewing sterilization process validation and product qualification documentation for multiple divisions and ensuring consistency with internal standards and global regulations.
- Research, review, and interpret sterilization studies and objectives associated with new equipment development, providing recommendations to optimize microbiological safety and process robustness.
- Work directly with notified bodies to convey sterilization strategies, including delivering training, setting priorities, and resolving day-to-day issues related to sterilization and microbiological controls.
- Participate in the development and writing of international standards for sterilization technologies, contributing subject matter expertise to influence industry best practices.
- Consult on sterilization and quality issues, support problem solving and resolution, and provide guidance to internal and external customers for sterilization testing and microbiological evaluation needs.
- Serve as a microbiology subject matter expert supporting contract manufactured devices and external manufacturing partners, ensuring appropriate microbiological controls and sterilization validation.
- Support acquisition due diligence activities by assessing microbiological and sterilization risks, and contribute to product integration and manufacturing transfer initiatives.
- Perform microbiological risk assessments for products, materials, manufacturing processes, facilities, and supplier changes, and document risk-based conclusions and recommendations.
- Author and review Microbiology Evaluation Reports (MBERs), technical assessments, and supporting scientific documentation that underpin product claims and regulatory submissions.
- Evaluate the microbiological impact of product, process, material, supplier, and facility changes, and recommend appropriate controls, validations, and mitigations.
- Support investigations, nonconformances, corrective and preventive actions (CAPAs), and other quality system activities that require microbiology expertise, ensuring thorough root cause analysis and effective remediation.
- Partner with cross-functional teams to assess microbiological considerations related to manufacturing operations, design changes, commercialization activities, and supplier controls.
- Provide microbiology support for new product development projects and product lifecycle management activities, ensuring sterilization and contamination control requirements are integrated from concept through commercialization.
- Participate in audits, inspections, and regulatory readiness activities, representing microbiology and sterilization functions and supporting responses to regulatory and customer inquiries.
- Support continuous improvement initiatives and implementation of microbiology-related quality system enhancements, driving standardization and robustness across sites and regions.
- Communicate microbiological risks, recommendations, and technical rationale clearly to stakeholders across multiple functions and geographic regions, influencing decisions through sound scientific reasoning.
- Independently manage multiple projects and priorities, ensuring timely completion of deliverables and effective coordination with global and cross-functional project teams.
- Travel approximately 1020% as needed to support site activities, audits, acquisitions, manufacturing transfers, project teams, and other business needs.

Requirements

- BS with 9-13yrs experience, MS with 7-11yrs experience, PhD with 4-8yrs experience.
- Demonstrated experience performing scientific evaluations and technical risk assessments, particularly in microbiology and sterilization contexts.
- Strong technical writing and documentation skills, including the ability to author and review scientific reports, regulatory documentation, and risk assessments.
- Proven ability to independently manage multiple projects and priorities in a dynamic environment.
- Strong communication skills with the ability to convey complex microbiological and sterilization concepts to diverse stakeholders.
- Effective stakeholder management capabilities, including collaboration with cross-functional and global teams.
- Solid understanding of quality systems within regulated industries and how microbiology and sterilization requirements integrate into those systems.

Additional Skills & Qualifications

- Medical device industry experience is strongly preferred, particularly in roles involving sterilization and microbiological controls.
- Experience supporting contract manufactured products or external manufacturing partners, including evaluation of their microbiological and sterilization practices.
- Experience supporting acquisitions, manufacturing transfers, or product transfer activities, with emphasis on assessing and integrating microbiological and sterilization requirements.
- Knowledge of contamination control, environmental monitoring, bioburden, sterilization processes, and microbiological risk assessment principles.
- Experience supporting CAPA, investigations, nonconformance management, and change management activities within a quality system framework.
- Familiarity with FDA regulations and other applicable global quality system requirements relevant to medical products and sterilization.
- Experience working in cross-functional and global project teams, contributing microbiology expertise to complex, multi-site initiatives.
- Experience presenting technical recommendations and microbiological risk assessments to leadership and project teams.
- Strong scientific and technical problem-solving skills, with the ability to analyze complex data and propose practical, risk-based solutions.
- Demonstrated risk-based decision-making capability, using scientific evidence and regulatory expectations to guide recommendations.
- Ability to influence stakeholders through clear scientific rationale and well-supported technical arguments.
- Excellent written and verbal communication skills, tailored to both technical and non-technical audiences.
- Strong organizational and project management abilities, including planning, prioritization, and follow-through.
- Ability to work effectively across multiple functions, sites, and geographic regions, building collaborative relationships and aligning on microbiology and sterilization strategies.

Work Environment This position is based in a hybrid work environment, combining on-site presence with remote work flexibility as aligned with business and project needs. The primary location is in Arden Hills, MN, operating on a first shift schedule typically from 8:00 a.m. to 4:30 p.m. You will work closely with manufacturing, quality, regulatory, and R&D teams in a regulated setting that emphasizes product quality, patient safety, and compliance with global standards. The role involves approximately 1020% travel to manufacturing sites, partner locations, and other facilities to support audits, acquisitions, manufacturing transfers, and project activities. The culture values collaboration, scientific rigor, continuous improvement, and cross-functional engagement, providing opportunities to contribute to international standards, global initiatives, and complex technical challenges.
Job Type & Location
This is a Contract position based out of Arden Hills, MN.
Pay and Benefits
The pay range for this position is $50.00 - $60.00/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)
Job Type & Location
This is a Contract position based out of Arden Hills, MN.
Application Deadline
This position is anticipated to close on Nov 9, 2026.
Workplace Type
This is a hybrid position in Arden Hills,MN. 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 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 process due to a disability,
please email [email protected] for other accommodation options.

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

Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a
condition of employment or continued employment. An employer who violates this law
shall 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 applications
and qualifications, but final decisions are made by our hiring team. By applying, you
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