GMP Process Engineer — Aseptic Biotech Manufacturing

Bio-Techne Singapore; Saint Paul (MN); 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

401k plan

ESPP

Job summary

Bio-Techne is seeking a GMP Process Engineer to provide technical support and ownership for GMP manufacturing operations supporting reagent production at the St. Paul facility.

You will partner with Manufacturing, Quality, Validation, and Engineering to drive process performance, regulatory compliance, and continuous improvement. Responsibilities include investigations, CAPAs, change controls, process validation, and collaboration with cross-functional teams to ensure compliant, efficient

Qualifications

• Bachelor's degree in biotechnology, biochemistry, biology, microbiology, chemical engineering, life sciences, or related field.
• 2-5 years of GMP manufacturing experience in biotech, diagnostics, biologics, pharma, 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 practices.
• Working knowledge of risk assessment tools and process mapping.

Responsibilities

• Provide day-to-day engineering and technical support to manufacturing; troubleshoot process and equipment issues.
• Lead investigations into deviations, non-conformances, contamination events, and excursions.
• Perform root cause analyses and support CAPA development.
• Support change controls, risk assessments, and technical evaluations.
• Execute process validation, equipment qualification, cleaning validation, and media fills.
• Monitor process performance and analyze data for improvements.
• Support contamination control, aseptic processing, and cleanroom practices.
• Prepare and review investigations, protocols, reports, and SOPs.
• Collaborate with Manufacturing, Quality, Validation, Engineering, and Regulatory teams.

Skills

Bioprocessing

Fermentation

Protein purification

Aseptic processing

CAPA investigations

Change control

Equipment qualification

Training in aseptic techniques

Root cause analysis

Process mapping

Risk assessment

Communication

Organizational skills

Education

Bachelor's degree in Life Sciences

Tools

Equipment qualification

Job description

Bio-Techne is seeking a GMP Process Engineer to provide technical support and ownership for GMP manufacturing operations supporting reagent production at the St. Paul facility.

You will partner with Manufacturing, Quality, Validation, and Engineering to drive process performance, regulatory compliance, and continuous improvement. Responsibilities include investigations, CAPAs, change controls, process validation, and collaboration with cross-functional teams to ensure compliant, efficient