Job Description
Job Purpose
To lead and execute Commissioning, Qualification, and Validation (CQV) activities for new and upgraded pharmaceutical manufacturing equipment and systems, ensuring compliance with GMP, FDA, EMA, and Singapore Health Sciences Authority (HSA) requirements.
(experience level – deltaV operations experience, commission of new equipment (tanks/ bioreactors etc), pharma manufacturing equipment (tanks, chrom column, ultra filtration etc, minimum 2 years relevant experience)
C&Q Execution
Develop and review C&Q documentation: Commissioning Plans, FAT/SAT protocols, IQ/OQ/PQ protocols, and summary reports.
Execute commissioning and qualification of pharma process equipment: bioreactors, fermenters, chromatography columns, ultrafiltration/diafiltration (UF/DF) systems, buffer/media preparation tanks, and CIP/SIP systems.
Lead deltaV automation system operational testing, including loop checks, HMI/SCADA verification, and alarm/sequence testing.
Project Support
...
To lead and execute Commissioning, Qualification, and Validation (CQV) activities for new and upgraded pharmaceutical manufacturing equipment and systems, ensuring compliance with GMP, FDA, EMA, and Singapore Health Sciences Authority (HSA) requirements.
(experience level – deltaV operations experience, commission of new equipment (tanks/ bioreactors etc), pharma manufacturing equipment (tanks, chrom column, ultra filtration etc, minimum 2 years relevant experience)
C&Q Execution
Develop and review C&Q documentation: Commissioning Plans, FAT/SAT protocols, IQ/OQ/PQ protocols, and summary reports.
Execute commissioning and qualification of pharma process equipment: bioreactors, fermenters, chromatography columns, ultrafiltration/diafiltration (UF/DF) systems, buffer/media preparation tanks, and CIP/SIP systems.
Lead deltaV automation system operational testing, including loop checks, HMI/SCADA verification, and alarm/sequence testing.
Project Support
...
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