GMP Bioprocess Engineer - Aseptic Ops & Process Improvement

Bio-Techne; Saint Paul (MN); On-site; USD 70,000 - 115,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401k + ESPP

Tuition reimbursement

Paid time off

Job summary

Bio-Techne in Saint Paul, MN seeks a GMP Process Engineer to provide technical support and ownership for GMP manufacturing of reagents. You will collaborate with Manufacturing, Quality, Validation, and Engineering to investigate deviations, support validations, and drive improvements in process performance and compliance.

The role requires a Bachelor’s in a life sciences field and 2–5 years GMP experience, with strong aseptic and CAPA skills.

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.
• Experience supporting validations and equipment qualifications.
• Ability to train personnel in aseptic techniques and GMP manufacturing practices.

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.

Skills

Bioprocessing knowledge

GMP manufacturing

Aseptic processing

CAPA & deviation

Process validation

Education

Bachelor’s degree in Biotechnology/ related

Job description

Bio-Techne in Saint Paul, MN seeks a GMP Process Engineer to provide technical support and ownership for GMP manufacturing of reagents. You will collaborate with Manufacturing, Quality, Validation, and Engineering to investigate deviations, support validations, and drive improvements in process performance and compliance.

The role requires a Bachelor’s in a life sciences field and 2–5 years GMP experience, with strong aseptic and CAPA skills.