Description

Lead engineering activities for a new clinical GMP manufacturing facility, supporting the design, modification, and maintenance of plant equipment and utilities.

Responsibilities

• Coordinate the design, modification, and maintenance of facility equipment and utility systems.
• Review and approve URS, System Impact Assessments, and C&Q reports with Validation, Quality, and Manufacturing teams.
• Generate asset enrollments and SOPs for facilities and utility systems.
• Establish service contracts for all facility and utility systems.
• Investigate and troubleshoot operational issues related to the facility and manufacturing equipment.

Required Skills

• 5+ years of experience in biologics, pharmaceuticals, or cell therapy.
• Applied knowledge of cGMP guidelines and quality standards.
• Experience in system start-up and commissioning.
• Proficiency in writing and managing SOPs.
• Experience guiding and managing junior engineers.
• Deep understanding of pharmaceutical and biotech production processes.
• Strong troubleshooting and problem-solving capabilities.
• Experience with at least two of: HVAC, Isolator and Filler Systems, Process Gas systems (CDA, CO2, O2, N2), Vacuum Systems, Environmental Monitoring Systems (Vaisala), Building Management Systems (BMS), or Chiller & Condenser systems.

Key Skills

Education

ANY GRADUATE