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Senior/lead Cqv Engineer

2 weeks 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