Biotech GMP Process Engineer: Drive Quality & Efficiency

BIO-TECHNE Corp; Minnesota; On-site; USD 70,000 - 115,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Short-term disability

Long-term disability

Pet insurance

401k with ESPP

Health Savings Account

FSA

Tuition reimbursement

Job summary

Bio-Techne is seeking a GMP Process Engineer to provide technical support and process ownership for GMP manufacturing operations at the St. Paul, MN site.

You will collaborate with Manufacturing, Quality, Validation, and Engineering teams to ensure compliant, efficient production of reagents and drive continuous improvement. The role requires 2–5 years of GMP experience in biotech or life sciences and a strong background in aseptic processing and bioprocessing.

Qualifications

• Bachelor's degree in biotechnology, biochemistry, biology, microbiology, chemical engineering or related discipline.
• 2–5 years of GMP manufacturing experience in biotechnology or life sciences.
• Experience with NC/deviation investigations, CAPA, and change control ownership.

Responsibilities

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

Skills

Bioprocessing

Fermentation

Protein purification

Aseptic processing

GMP knowledge

CAPA

Root cause analysis

Process mapping

Education

Bachelor’s degree in Life Sciences or related field

Tools

Equipment qualification

Job description

Bio-Techne is seeking a GMP Process Engineer to provide technical support and process ownership for GMP manufacturing operations at the St. Paul, MN site.

You will collaborate with Manufacturing, Quality, Validation, and Engineering teams to ensure compliant, efficient production of reagents and drive continuous improvement. The role requires 2–5 years of GMP experience in biotech or life sciences and a strong background in aseptic processing and bioprocessing.