Senior CQV Process Engineer

8 hours ago

Singapore INTEGRIX SOLUTIONS PTE. LTD. Full time

About the Role: We invite highly motivated individuals to join our team in providing support to our clients' biomanufacturing facilities. In this role, you will be tasked with performing pre-commissioning checks and detailed testing, troubleshooting process/equipment issues, preparing comprehensive reports, collaborating with cross-functional teams, and ensuring strict adherence to pharmaceutical GMP and regulatory standards.Key Responsibilities: Execution: Plan and execute CQV activities for biomanufacturing facilities, utilities (like WFI or HVAC), and bioprocess equipment. Compliance: Ensure all activities and documentation meet GMP, regulatory requirements and company procedures. Coordination: Work with engineering, project, quality, and vendor teams to coordinate and execute CQV activities. Troubleshooting: Identify and resolve issues encountered during the commissioning and qualification process. Documentation: Develop and review Commissioning, Qualification, and Validation (CQV) lifecycle documentation , including User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) , and Performance Qualification (PQ) . Requirements: Diploma in a Science or Engineering related field, such as Biotechnology, Bioprocess Engineering, Biochemistry, Microbiology, Chemical Engineering. Minimum 5 years experience in supporting bioprocessing operations such as fermentation, cell culture, or downstream processing. Knowledge of process automation and basic instrumentation. Excellent troubleshooting and communication skills Willing to accept a 1 year contract position

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