GMP Process Engineer: Biotech Manufacturing & Compliance

Bio-Techne; Saint Paul (MN); Presencial; USD 70.000 - 115.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision insurance

Life insurance

Disability insurance (short & long)

401k with employer match

ESPP

HSA

FSA

Tuition reimbursement

Mentorship programs

Descripción de la vacante

Bio-Techne in Saint Paul, MN is seeking a GMP Process Engineer to provide technical ownership for GMP manufacturing operations, ensuring product quality and regulatory compliance.

You will partner with Manufacturing, Quality, Validation and Engineering to support daily operations, lead deviation investigations, and drive continuous improvement in aseptic processing and cleaning validation.

Formación

• Bachelor’s degree in biotechnology, Biochemistry, Biology, or related discipline.
• 2–5 years of GMP manufacturing experience in biotech or life sciences.
• Experience with NC/deviation investigations, CAPA, and change control ownership.

Responsabilidades

• Provide day-to-day engineering support to manufacturing and troubleshoot process issues.
• Lead investigations related to deviations, non-conformances, contamination events, and excursions.
• Perform root cause analyses and support CAPAs and change controls.
• Support validation activities, equipment qualification, cleaning validation and media fills.
• Monitor process performance and analyze data to identify trends and improvements.
• Collaborate with cross-functional teams to ensure compliant and efficient operations.

Conocimientos

Bioprocessing knowledge

GMP manufacturing

Root cause analysis

CAPA

Process validation

Educación

Bachelor’s degree in biotechnology or related life sciences

Descripción del empleo

Bio-Techne in Saint Paul, MN is seeking a GMP Process Engineer to provide technical ownership for GMP manufacturing operations, ensuring product quality and regulatory compliance.

You will partner with Manufacturing, Quality, Validation and Engineering to support daily operations, lead deviation investigations, and drive continuous improvement in aseptic processing and cleaning validation.