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 , including User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), , and .
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.
- More experienced candidates will be considered for Lead role.
- Knowledge of process automation and basic instrumentation.
- Excellent troubleshooting and communication skills
