Process Project Coordinator

il y a 7 jours


Laeken, Belgique Blackfield Associates Temps plein

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



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