Process Project Coordinator

Process Project Close-Out Coordinator

This role supports a new greenfield gene therapy manufacturing facility, a large-scale single-use biotech plant with fully customized PCS7 process control systems.

Key Accountabilities

Technical Coordination

• Plan and coordinate all technical startup activities
• Lead technical troubleshooting with engineering contractors (issue definition, root cause, corrective actions)
• Track implementation of corrective actions and coordinate re-testing as required
• Ensure process systems are ready for water runs and handover
• Lead handover to users and maintenance teams

Documentation & Compliance

• Support and complete SAT activities within area of expertise
• Review, approve, and update technical documentation
• Manage technical changes to ensure URS compliance
• Coordinate end-user training and provide documentation for handover
• Drive efficient handover, including punch-list follow-up
• Ensure adherence to documentation strategy

HSE

• Ensure all activities comply with HSE and site safety requirements

Education & Experience

Education

• Bachelor’s or Master’s degree in Engineering or equivalent

Experience

• Minimum 5 years’ experience in pharmaceutical/biotech projects with engineering offices
• Experience in project handover and startup phases
• Strong background in regulated environments (GMP)
• Experience with single-use systems and large-scale equipment installation and commissioning
• Good understanding of EHS and quality requirements

Competencies & Technical Skills

• Expertise in USP and DSP process equipment (bioreactors, filtration, chromatography, single-use skids, mixers)
• Strong knowledge of media and buffer preparation systems
• Ability to read, interpret, and set up PFDs and P&IDs
• Effective collaboration with engineering contractors and operations teams