Senior/Lead CQV Engineer

1 week ago

Singapore INTEGRIX SOLUTIONS PTE. LTD. Full time $90,000 - $120,000 per year

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.
  • More experienced candidates will be considered for Lead role.
  • Knowledge of process automation and basic instrumentation.
  • Excellent troubleshooting and communication skills

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