C&Q Execution Lead Engineer
Core
Lead end-to-end commissioning, qualification, and handover of process and utility systems for a new Antibody Drug Conjugate (ADC) manufacturing facility.
Role type
Senior IC C&Q Execution Lead Engineer
Builds
Commissioned and qualified process/utility systems for ADC manufacturing
Domain
Biopharmaceutical manufacturing (ADC)
Required skills
C&Q execution, cGMP compliance, risk-based validation, team leadership, FAT/SAT coordination, troubleshooting, DCS/PLC commissioning, GDP/ALCOA+ adherence
Preferred skills
PMP certification, high-containment/HPAPI experience, digital validation platforms
Technologies
DCS, PLCs, digital validation platforms
Responsibilities
Execute C&Q scope from Mechanical Completion to Handover, lead C&Q engineering teams, act as owner's representative for EPCM contractors, witness FAT/SAT and pre-commissioning activities, perform commissioning and shakedown testing, coordinate daily execution support, troubleshoot mechanical/electrical/control issues, ensure GDP and ALCOA+ compliance, track and close out deficiencies.
Seniority
Senior, hands-on IC