Associate Engineer - Pilot Plant

Role Summary

Associate Engineer - Pilot Plant role providing hands-on operational and technical support within the pilot plant, bridging engineering and scientific disciplines to ensure robust process performance, equipment reliability, and technology transfer from process development to manufacturing scale. Contributes to process optimization, experimental execution, and equipment design to enable efficient and reproducible biologics production.

Responsibilities

• Pilot Plant Operations & Support: Perform day-to-day pilot plant equipment involving upstream and downstream bioprocess equipment; support and troubleshoot process deviations, ensuring minimal disruption to pilot campaigns; partner with process scientists to plan and execute engineering runs and process characterization studies.
• Equipment Reliability & Optimization: Provide hands-on support for equipment setup, operation, calibration, and maintenance; implement preventive maintenance and reliability improvement initiatives across pilot-scale bioreactor systems and support equipment; identify equipment risks and drive the development of risk mitigation strategies to enhance process consistency.
• Scientific & Engineering Analysis: Analyze experimental and process data from both pilot and bench-scale studies to identify performance trends and opportunities for optimization; apply engineering and bioprocess principles to improve process performance, including yield, scalability, and robustness; utilize data-driven problem-solving methods to inform process and equipment improvements.
• Continuous Improvement & Innovation: Lead or participate in initiatives to improve process efficiency, reduce cycle times, and enhance product quality; support new product introductions and technology transfers by assessing process fit and implementing pilot-scale modifications as needed; collaborate cross-functionally with process development, manufacturing, and engineering teams to ensure smooth scale-up and knowledge transfer.
• Compliance & Documentation: Maintain accurate and complete documentation of experimental work, pilot operations, and equipment modifications in compliance with GMP and internal quality systems.

Qualifications

• Basic Qualifications:
  • High school diploma / GED and 6 years of engineering or bioprocess operations experience OR
  • Associate‚Äôs degree and 4 years of engineering or bioprocess operations experience OR
  • Bachelor‚Äôs degree
• Preferred Qualifications:
  • Hands-on experience with pilot plant or manufacturing-scale bioprocess equipment (bioreactors, filtration skids, chromatography systems, etc.)
  • Familiarity with cell culture or fermentation processes, including setup, inoculation, monitoring, and harvest operations.
  • Experience with scale-down models for process development and technology transfer.
  • Understanding of GMP and biopharmaceutical production environments.
  • Demonstrated ability to troubleshoot and optimize process equipment and control systems.
  • Knowledge of change control, nonconformance management, and validation principles.
  • Strong analytical and problem-solving skills using data-driven methods.
  • Flexibility to support pilot plant operations outside of standard working hours as needed (evenings, weekends, and on-call support).

Skills

• Analytical thinking and data-driven problem solving
• Bioprocess equipment operation and troubleshooting
• Process optimization and design of experiments
• Cross-functional collaboration
• Documentation and compliance with GMP

Education

• As listed under Basic Qualifications

Additional Requirements

• Flexibility to support pilot plant operations outside standard working hours as needed (evenings, weekends, and on-call).