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:

• Degree in a Science or Engineering related field, such as Biotechnology, Bioprocess Engineering, Biochemistry, Microbiology, Chemical Engineering.
• Minimum 8 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