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Upstream Process Specialist
2 weeks ago
Lead commissioning activities, oversee project execution, and ensure compliance with Good Manufacturing Practice (GMP) and regulatory requirements. This role focuses on bioprocess equipment for upstream operations such as bioreactors, fermenters, media preparation, and associated utilities.
The ideal candidate will possess a Bachelor's or Master's degree in Engineering, Biotechnology, Bioprocess, or related discipline, along with minimum 5 years of experience in commissioning, project management, or engineering within the pharmaceutical/biotech industry. Strong expertise in upstream bioprocess equipment (bioreactors, fermenters, CIP/SAT systems, utilities) is necessary.
- Manage commissioning, qualification, and validation of upstream bioprocessing equipment and systems.
- Oversee project planning, execution, and delivery within agreed timelines and quality standards.
- Collaborate with cross-functional teams (Engineering, Manufacturing, Quality, EHS, and Validation).
- Ensure project documentation is in line with GDP, GxP, and regulatory guidelines.
- Provide technical expertise on upstream process equipment and utilities.
- Identify risks, troubleshoot issues, and implement corrective and preventive actions.
Bachelor's or Master's degree in Engineering, Biotechnology, Bioprocess, or related discipline required. Minimum 5 years of experience in commissioning, project management, or engineering within the pharmaceutical/biotech industry. Strong expertise in upstream bioprocess equipment (bioreactors, fermenters, CIP/SAT systems, utilities) necessary.
