GMP Process Engineer

Bio-Techne • Saint Paul, MN

3d • Onsite

About The Position

The GMP Process Engineer provides technical support and process ownership for GMP manufacturing operations supporting reagent production at Bio-Techne’s St. Paul facility. The role is a key technical resource for assigned manufacturing and aseptic processing operations, supporting consistent process performance, product quality, regulatory compliance, and operational efficiency. The engineer partners with Manufacturing, Quality, Validation, and Engineering teams to support daily operations, investigate process deviations, implement corrective actions, support validation activities, and drive continuous improvement. The position also supports reliable, compliant manufacturing processes and the growth of Bio-Techne’s GMP operations.

The work is performed onsite in a laboratory and production environment during standard business hours, with occasional schedule variation depending on production needs. The environment includes exposure to chemicals, reagents, and standard laboratory equipment. Physical requirements include handling materials weighing 5–50 lbs, standing and walking, and performing repetitive laboratory tasks for extended periods.

Requirements

• Bachelor’s degree in biotechnology, biochemistry, biology, microbiology, chemical engineering, life sciences, or a related discipline.
• 2–5 years of GMP manufacturing experience in biotechnology, diagnostics, biologics, pharmaceutical, or life sciences industries.
• Broad bioprocessing knowledge and manufacturing support experience.
• Knowledge of fermentation, protein purification, formulation, filling, or aseptic processing.
• Experience with non-conformance/deviation investigations, CAPA, and change control ownership.
• Experience supporting validations and equipment qualifications.
• Ability to train personnel in aseptic techniques and GMP manufacturing practices.
• Working knowledge of Five Whys, Fishbone Analysis, FMEA, process mapping, and risk assessment tools.
• Strong organizational skills, including the ability to manage and prioritize multiple projects.
• Strong communication skills with stakeholders at different levels of the organization.
• Ability to lift and handle materials weighing 5–50 lbs.
• Ability to stand, walk, and perform repetitive laboratory tasks for extended periods.
• Work authorization that does not now or in the future require visa sponsorship for employment authorization in the United States.

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 compliance and operational readiness.

Benefits

• Medical, dental, vision, life, short-term disability, and long-term disability insurance starting on day one.
• Pet insurance and legal and ID shield benefits.
• 401(k) plans.
• Employee stock purchase plan (ESPP).
• Health Savings Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
• Mentorship, promotional opportunities, training and development, tuition reimbursement, and internship programs.
• Employee resource groups, paid volunteer time off, employee events, and charity drives.
• Accrued leave policy with paid holidays, paid time off, and paid parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level