GMP Process Engineer

Research & Diagnostic Systems, Inc.; Saint Paul (MN); On-site; USD 70,000 - 115,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life Insurance

Short-term disability

Long-term disability

Pet insurance

ID shield

401k plans

ESPP

HSA

FSA

Dependent Care FSA

Mentorship

Training and development

Tuition reimbursement

Employee resource groups

Volunteer paid time off

Employee events

Charity drives

Paid holidays

Paid time off

Paid parental leave

Job summary

Bio-Techne's GMP Process Engineer role at the St. Paul facility provides technical ownership and support for GMP manufacturing of reagents.

You will partner with Manufacturing, Quality, Validation, Engineering, and Regulatory teams to maintain compliant, high-quality processes and drive continuous improvement. Responsibilities include investigations of deviations, CAPA management, change control, process validation, equipment qualification, and ongoing process verification, with emphasis on

Qualifications

• Bachelor’s degree in biotechnology, Biochemistry, Biology, Microbiology, Chemical Engineering, Life Sciences, or related discipline.
• 2 - 5 years of GMP manufacturing experience in biotechnology, diagnostics, biologics, pharmaceutical, or life sciences industries.
• Experience with NC/deviation investigations, CAPA, and change control ownership.

Responsibilities

• Provide day-to-day engineering and technical support to manufacturing, troubleshooting process and equipment-related issues.
• Lead investigations related to deviations, non-conformances, contamination events, environmental monitoring excursions, and out-of-trend results.
• Perform root cause analyses and support the development and implementation of effective CAPAs.
• Support process validation, equipment qualification, cleaning validation, media fills, and ongoing process verification activities.
• Collaborate with Manufacturing, Quality, Validation, Engineering, and Regulatory teams to support compliant and efficient manufacturing operations.

Skills

Bioprocessing knowledge

Fermentation

Protein purification

Aseptic processing

CAPA investigations

Change control

Equipment qualification

Validation

GMP manufacturing

Training personnel

Documentation

Education

Bachelor's degree in biotechnology/related field

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: $69,800.00 - $114,800.00

Position Summary:

The GMP Process Engineer position is to provide technical support and process ownership for GMP manufacturing operations supporting reagent production at our St. Paul facility. This role serves as a key technical resource for assigned manufacturing and aseptic processing operations, helping to ensure consistent process performance, product quality, regulatory compliance, and operational efficiency. The GMP Process Engineer partners with Manufacturing, Quality, Validation, and Engineering teams to support daily operations, investigate process deviations, implement corrective actions, support validation activities, and drive continuous improvement initiatives. This position plays an important role in maintaining reliable, compliant manufacturing processes while supporting the growth and advancement of Bio-Techne's GMP operations.

Key Responsibilities:

Provide day-to-day engineering and technical support to manufacturing, troubleshooting process and equipment-related issues. Lead investigations related to deviations, non-conformances, contamination events, environmental monitoring excursions, and out-of-trend results. Perform root cause analyses using structured problem-solving tools and support the development and implementation of effective CAPAs. Support process-related change controls, risk assessments, and technical impact evaluations. Execute and support process validation, equipment qualification, cleaning validation, media fills, and ongoing process verification activities. Monitor process performance and analyze manufacturing data to identify trends and improvement opportunities. Support contamination control initiatives and provide technical guidance on aseptic processing and cleanroom practices. Author and review technical documentation, including investigations, protocols, reports, risk assessments, and operating procedures. Collaborate with Manufacturing, Quality, Validation, Engineering, and Regulatory teams to support compliant and efficient manufacturing operations. Support technology transfers, process optimization, and implementation of new manufacturing capabilities. Support internal audits, regulatory inspections, and continuous improvement initiatives to maintain a state of compliance and operational readiness.

QUALIFICATIONS Education and Experience:

Bachelor’s degree in biotechnology, Biochemistry, Biology, Microbiology, Chemical Engineering, Life Sciences, or related discipline. 2 - 5 years of GMP manufacturing experience in biotechnology, diagnostics, biologics, pharmaceutical, or life sciences industries.

Knowledge, Skills, and Abilities:

Broad bioprocessing knowledge and manufacturing support experience. Knowledge of fermentation, protein purification, formulation, filling, or aseptic processing. Experience with NC/deviation investigations, CAPA, and change control ownership. Experience supporting validations and equipment qualifications. Ability to train personnel in aseptic techniques and GMP manufacturing practices. Working knowledge of Five Whys, Fishbone Analysis, FMEA, process mapping, and risk assessment tools. Strong organizational skills with the ability to manage and prioritize multiple projects. Strong communication skills with stakeholders in different levels of the organization.

Working Conditions:

Work performed in a laboratory and production environment with exposure to chemicals, reagents, and standard lab equipment. Standard schedule hours with occasional variation depending on production needs. Onsite work required during standard business hours.

Physical Requirements:

Ability to lift and handle materials weighing 5–50 lbs. Ability to stand, walk, and perform repetitive laboratory tasks for extended periods.

Why Join Bio-Techne:

• medical
• dental
• vision
• life
• short-term disability
• long-term disability
• pet
• legal and ID shield

• 401k plans
• an employee stock purchase plan (ESPP)
• Health Saving Account (HSA)
• Flexible Spending Account (FSA)
• Dependent Care FSA

• mentorship
• promotional opportunities
• training and development
• tuition reimbursementinternship programsmore

• employee resource groups
• volunteer paid time off
• employee events
• charity drives

• paid holidays
• paid time off
• 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.

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 [e-mail] for assistance.

Bio-Techne empowers researchers in Life Science and Clinical Diagnostics by providing high-quality reagents, instruments, custom manufacturing, and testing services. Our family of brands creates a unique portfolio of products and services. Science is our passion; it drives us to collaborate, develop, and manufacture award-winning tools that help researchers achieve reproducible and consistent results.