Pay Range:

$69,800.00 - $114,800.00

Position Summary:

The GMP Process Engineer position is to provide technical support and process ownership for GMP manufacturing operations supporting reagent production at our St. Paul facility. This role serves as a key technical resource for assigned manufacturing and aseptic processing operations, helping to ensure consistent process performance, product quality, regulatory compliance, and operational efficiency.

The GMP Process 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 initiatives. This position plays an important role in maintaining reliable, compliant manufacturing processes while supporting the growth and advancement of Bio-Techne's GMP operations.

Key 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.

QUALIFICATIONS

Education and Experience:

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.

Knowledge, Skills, and Abilities:

Broad bioprocessing knowledge and manufacturing support experience.
Knowledge of fermentation, protein purification, formulation, filling, or aseptic processing.
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.
Working knowledge of Five Whys, Fishbone Analysis, FMEA, process mapping, and risk assessment tools.
Strong organizational skills with the ability to manage and prioritize multiple projects.
Strong communication skills with stakeholders in different levels of the organization.

Working Conditions:

Work performed in a laboratory and production environment with exposure to chemicals, reagents, and standard lab equipment.
Standard schedule hours with occasional variation depending on production needs.
Onsite work required during standard business hours.

Physical Requirements:

Ability to lift and handle materials weighing 5–50 lbs.Ability to stand, walk, and perform repetitive laboratory tasks for extended periods.

BioTechne

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GMP Process Engineer