Lead and manage new solution system, sterilization, and process-related development projects, including outsourced validation and revalidation programs.
Oversee and investigate any testing, process, or equipment failures related to sterilization, solution systems, and outsourced validation/revalidation (including those not limited to the Singapore site).
Perform or supervise microbiological tests and chemical analyses as required, ensuring all testing is conducted in accordance with established procedures.
Prepare, review, and ensure proper documentation of validation/revalidation protocols, reports, and sterilization procedures.
Monitor and maintain the operation and performance of sterilization and solution system facilities to ensure compliance and efficiency.
Serve as a subject matter expert and appointed trainer; provide technical guidance and training to new laboratory staff and outsourced partners when required.
Manage laboratory consumables, including procurement, inventory control, and expenditure monitoring.
Oversee calibration activities—review internal records, coordinate external calibration, maintain the calibration master list, and ensure all equipment used for sterilization and validation has valid calibration status.
Job Requirements
Degree in Chemistry, Biochemistry, Microbiology, or a related field.
Experience is not required, though it will be an advantage.
Preferably familiar with ISO 13485 and/or ISO 9001 standards.
Knowledge of QC tools and statistical techniques will be an added advantage.
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