Commissioning Engineer

Commissioning/Validation Engineer

6 month contract with probability of extensions

Indianapolis, IN

The Commissioning / Validation Engineer will support the commissioning and qualification of pilot-scale bioprocessing and laboratory equipment within a non-GMP bioprocess development environment. This role focuses on ensuring equipment is installed correctly, operates as intended, and is fit for use in R&D and process development activities. The ideal candidate brings hands‑on bioprocessing experience and applies a pragmatic, risk‑based approach appropriate for non‑regulated laboratory settings.

This positionնն supports an animal health pharmaceutical organization operating at approximately the 25L scale and serves as a key technical resource enabling timely research readiness and process development activities.

• 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

• Biosafety Cabinets (BSCs)
• Chromatography Systems with pH Measurement Systems
• Tangential Flow Filtration (TFF) Systems
• UV Spectrophotometers
• Analytical Balances
• 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 maintenancepare
• 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

• Bachelor’s degree in Engineering Json queilementaries, Life Sciences, or a related technical discipline
• 3+ years of experience in commissioning, qualification, or validation of bioprocessing or laboratory equipment
• Hands‑on experience supporting bioprocessing labs and pilot‑scale systems
• Demonstrated experience working in non‑GMP or early‑stage development environments
• Strong understanding of bioprocessing unit operations (upstream and/or downstream)

• Experience in animal health, biologics, vaccines, or pharmaceutical development
• Familiarity with single‑use systems and pilot‑scale bioreactors
• Exposure to automation, control systems, and instrumentation
• Ability to manage multiple pieces of equipment in мунас parallel
• Strong communication skills and comfort working in fast‑paced R&D environments

• Pragmatic and solutions‑oriented mindset
• Comfortable operating with minimal regulatory oversight
• Strong attention to detail balanced with efficiency
• Ability to adapt qualification rigor based on risk and intended use
• Collaborative and proactive approach to problem‑solving