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Medasource · 16 hours ago

Commissioning Engineer

Indianapolis, IN

Full-time

Onsite

Mid Level

3+ years exp

Medasource is an organization supporting the animal health pharmaceutical sector, and they are seeking a Commissioning/Validation Engineer to support the commissioning and qualification of bioprocessing and laboratory equipment. The role focuses on ensuring equipment is installed correctly and operates as intended in a non-GMP bioprocess development environment.

Health CareMedical

Growth Opportunities

Hiring Manager

Jenna Kimack

Responsibilities

Execute commissioning and qualification activities for pilot-scale bioprocessing and analytical equipment in a non-GMP environment

Perform and document Installation Qualification (IQ) and limited Operational Qualification (OQ) activities, as appropriate

Verify equipment installation, utilities, safety features, alarms, and basic functional performance

Support equipment start-up, shakedown runs, and handover to end users

Apply risk-based decision-making to define appropriate qualification scope and documentation

Provide commissioning and qualification support for, but not limited to, the following equipment:

Biosafety Cabinets (BSCs)

Bioreactor Controller Systems (≈25L scale)

Bioreactor Circulation Chillers

Floor Centrifuges

Chromatography Systems with pH Measurement Systems

Tangential Flow Filtration (TFF) Systems

UV Spectrophotometers

Analytical Balances

Laboratory Refrigerators (2–8°C)

Freezers (-20°C and -80°C)

Review and leverage vendor documentation, manuals, and FAT/SAT materials

Author and execute concise, fit-for-purpose commissioning and qualification documentation

Document deviations, issues, and resolutions in a clear and pragmatic manner

Support SOPs, work instructions, and user guidance related to equipment operation and maintenance

Ensure documentation aligns with internal quality standards for non-GMP environments

Partner closely with R&D, Process Development, Engineering, and Lab Operations teams

Serve as a technical liaison between equipment vendors and internal stakeholders

Support lab readiness timelines and project milestones

Provide guidance on equipment use, limitations, and best practices

Qualification

Commissioning bioprocessing equipmentQualification of laboratory equipmentBioprocessing experienceRisk-based qualification strategiesNon-GMP environment experienceBioprocessing unit operationsCollaborative problem-solvingCommunication skillsAttention to detail