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Aseptic Process Engineer Jobs in Minnesota (NOW HIRING)

Nucleus RadioPharma

Senior Microbiologist

Rochester, MN · On-site

$80K - $120K/yr

... aseptic processing support, investigations, and data trending, partnering cross‑functionally with Manufacturing, Quality Assurance, Engineering, Validation, and Technical Operations. Working with ...

Evergen

Sterility Assurance Engineer 2

Eden Prairie, MN · On-site

$85K - $100K/yr

Serve as a site SME for microbiology, sterility assurance, aseptic processing, and contamination control. * Implement and continuously improve the site Contamination Control Strategy (CCS). * Oversee ...

BioMADE

Shift Supervisor

Maple Grove, MN · On-site

$95K - $115K/yr

... achieve aseptic operation in the fermentation area, ensuring team members understand these ... Upstream or Downstream process engineer closely tied to supporting operations or process ...

Evergen

Sr. Design Transfer Engineer

Eden Prairie, MN · On-site

$110 - $130/hr

Problem-solving and investigative mindsetStrong knowledge of microbiological techniques and aseptic processing Travel N/A Physical Requirement * Move or lift objects up to 25 pounds * Frequent (>75 ...

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All JobsAseptic Process Engineer JobsAseptic Process Engineer Jobs in Minnesota

Aseptic Process Engineer information

See Minnesota salary details

$34.8K

$89.5K

$133.8K

How much do aseptic process engineer jobs pay per year?

As of Sep 5, 2026, the average yearly pay for aseptic process engineer in Minnesota is $89,511.00, according to ZipRecruiter salary data. Most workers in this role earn between $73,700.00 and $100,900.00 per year, depending on experience, location, and employer.

What is an aseptic process engineer?

Aseptic process engineers are professionals who design, develop, and maintain sterile manufacturing systems, primarily in the pharmaceutical, biotechnology, and food industries. Their main responsibility is to ensure that products are produced in a contamination-free environment, using processes that prevent the introduction of microorganisms. This involves overseeing the design of cleanrooms, validating equipment, developing standard operating procedures, and ensuring regulatory compliance. Aseptic process engineers work closely with quality assurance teams to maintain high standards of product safety and efficacy. Their expertise is crucial for industries where product sterility is critical to consumer safety.

What are the key skills and qualifications needed to thrive as an aseptic process engineer, and why are they important?

Aseptic Process Engineers need a strong background in chemical, mechanical, or biomedical engineering, along with experience in aseptic manufacturing environments and a solid understanding of GMP regulations. Familiarity with process automation systems, sterilization equipment, and industry certifications such as Six Sigma or Lean Manufacturing are often required. Attention to detail, strong problem-solving abilities, and effective communication are vital soft skills for ensuring product quality and process efficiency. These skills are crucial for maintaining sterile conditions, regulatory compliance, and the safe production of pharmaceuticals or biotechnology products.

What are some common challenges faced by aseptic process engineers, and how can they be addressed?

Aseptic Process Engineers often encounter challenges such as maintaining strict sterility standards, troubleshooting equipment issues, and ensuring compliance with changing regulatory requirements. Addressing these challenges requires strong attention to detail, proactive communication with cross-functional teams, and staying current with industry best practices and regulations. Collaborating closely with quality assurance, production, and maintenance teams helps to identify and resolve issues quickly, ensuring that processes remain efficient and compliant.

What is the difference between Aseptic Process Engineer vs Pharmaceutical Manufacturing Technician?

AspectAseptic Process EngineerPharmaceutical Manufacturing Technician
CredentialsBachelor's degree in engineering, life sciences, or related field; GMP trainingHigh school diploma or associate degree; GMP training often required
Work EnvironmentCleanroom, sterile environments, manufacturing facilitiesManufacturing floors, production areas, sometimes cleanrooms
Industry UsageDesign, optimize, and validate aseptic processes in pharmaOperate equipment, assemble products, support manufacturing

The Aseptic Process Engineer focuses on designing and validating sterile manufacturing processes, requiring specialized engineering knowledge. In contrast, the Pharmaceutical Manufacturing Technician handles day-to-day production tasks, often with less formal education but essential for maintaining manufacturing flow. Both roles are vital in pharmaceutical production but differ in responsibilities and qualifications.

What are popular job titles related to Aseptic Process Engineer jobs in Minnesota?

For Aseptic Process Engineer jobs in Minnesota, the most frequently searched job titles are:

What job categories do people searching Aseptic Process Engineer jobs in Minnesota look for?

The top searched job categories for Aseptic Process Engineer jobs in Minnesota are:

Aseptic Process Engineer jobs near you
Infographic showing various Aseptic Process Engineer job openings in Minnesota as of August 2026, with employment types broken down into 100% Full Time. Highlights an 89% In-person, and 11% Hybrid job distribution, with an average salary of $89,511 per year, or $43 per hour.

Sterility Assurance Program Manager

Bio-Techne

Saint Paul, MN • On-site

$78K - $128K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 18 days ago

Bio-Techne rating

8.4

Company rating: 8.4 out of 10

Based on 15 frontline employees who took The Breakroom Quiz

Job description

By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.
Pay Range:
$78,100.00 - $128,500.00
Position Summary:
The Sterility Assurance Program Manager is responsible for the development, implementation, oversight, and continuous improvement of the sterility assurance program within a GMP-regulated manufacturing environment. This role ensures that all processes related to aseptic processing, sterilization, and contamination control meet regulatory requirements and internal quality standards to guarantee product sterility.
Key Responsibilities:
  • Own and manage the sterility assurance program, including policies, procedures, and related documentation.
  • Develop, implement, and maintain sterility assurance programs including sterilization validations, bioburden testing, endotoxin testing, and contamination control strategies.
  • Lead cross-functional teams to assess sterility risks and develop mitigation plans.
  • Oversee validation and monitoring of sterilization processes including aseptic processing, sterilizer cycles, and environmental controls.
  • Own the planning, execution, and approval of aseptic process simulations (media fills) ensuring compliance with regulatory requirements and internal standards.
  • Complete aseptic process validations, including protocol development, execution, data review, and final report generation.
  • Ensure qualification and ongoing training of manufacturing personnel in aseptic techniques, contamination control, and sterility requirements.
  • Prepare detailed technical reports and documentation related to sterility assurance activities for internal review and regulatory submissions.
  • Ensure compliance with applicable regulations and standards (e.g., FDA, EMA, USP, ISO), with specific knowledge and application of EU GMP Annex 1 guidelines.
  • Collaborate with Quality Assurance, Manufacturing, Microbiology, and Engineering departments to drive continuous improvement initiatives.
  • Manage deviation investigations, root cause analysis, and CAPA related to sterility assurance issues.
  • Conduct training and provide guidance on sterility assurance principles and best practices.
  • Support regulatory inspections and audits, acting as the subject matter expert for sterility assurance.
  • Monitor sterility assurance metrics and prepare reports for senior management.
  • Stay updated with advances in sterility assurance technologies, regulatory changes, and industry best practices including Annex 1 revisions.

Qualifications:
  • Strong knowledge of aseptic processing, sterilization methods, contamination control, microbiological testing, aseptic process simulations (media fills), and process validations.
  • Proven experience in the qualification and training of manufacturing personnel in aseptic techniques and sterility assurance requirements.
  • Experience owning, executing, and reporting on aseptic process validations in compliance with regulatory standards.
  • In-depth knowledge of EU GMP Annex 1 and the ability to apply its requirements effectively in a manufacturing environment.
  • Familiarity with regulatory requirements including FDA cGMP, EMA, USP <71>, ISO 13485, and related standards.
  • Experience with risk management methodologies and tools (e.g., FMEA, HACCP).
  • Proven experience in managing sterility assurance programs and leading cross-functional initiatives.
  • Excellent analytical, problem-solving, and project management skills.
  • Strong communication and interpersonal skills.
  • Ability to influence and drive changes in a complex, regulated environment.
  • Detail-oriented with strong documentation and record-keeping skills.

Education and Experience:
  • Bachelor's degree in biology, Microbiology, or Engineering. Advanced degree preferred.
  • Minimum of 5 years of experience in sterility assurance, quality assurance, or a related role within a GMP manufacturing environment.

Knowledge, Skills, and Abilities:
  • Strong knowledge of aseptic processing, sterilization methods, contamination control, microbiological testing.
  • Experience with aseptic process simulations (media fills) including planning, execution, and approval.
  • Proven experience in completing aseptic process validations and report generation.
  • Ability to qualify and train manufacturing personnel in aseptic techniques and sterility assurance standards.
  • Strong analytical and problem-solving skills with attention to detail.
  • Good communication skills, able to clearly document and report findings.
  • Effective project and time management skills.
  • Ability to work collaboratively across multiple departments and influence stakeholders.

Preferred Skills:
  • Experience with sterile dosage forms manufacturing.
  • Proficiency with electronic quality management systems (eQMS).
  • Advanced degree in relevant scientific discipline.

Working Conditions:
  • Onsite work required in GMP manufacturing environments, laboratories, and controlled production areas.
  • Exposure to biologics, chemicals, and standard bioprocessing equipment.
  • Work may require standing, walking, or operating equipment for extended periods.
  • May require occasional early hours or weekends based on production schedules.

Physical Requirements:
  • Ability to lift and move items up to 40-50 lbs.
  • Ability to wear PPE required for clean room operations.
  • Ability to maneuver equipment such as carts, cylinders, or supplies as needed.
  • Extended periods of standing, walking, or working at production equipment and clean room environment.
  • Extended periods sitting and performing computer work.

Why Join Bio-Techne:
  • We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
  • We invest in our employees' financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
  • We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
  • We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
  • We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.
  • We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

Bio-Techne is an E-Verify Employer in the United States.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.
This position requires work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (e.g., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant work status). If you require a reasonable accommodation to complete an application, participate in an interview, or take part in any other stage of the recruitment process, please contact hr@bio-techne.com for assistance.

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