GMP Process Engineer — Manufacturing & Compliance

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

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