About the Job
Start Date: May 3 to 10th
The responsibility will include the support of the Harvest manufacturing, technical performance, analysis of specific bioreactor related functionalities, and troubleshooting equipment upsets and failures. Manufacturing Engineer will be responsible for the Centrifuge, Harvest Collection tanks, and Depth Filters CIP/SIP functionality, process automation functionality, ensuring that the design and operation complies with safe and quality compliant requirements. The Manufacturing Engineer will perform analysis of the manufacturing data, historical review of the performance parameters, conduct quality and safety related investigations. The manufacturing engineer will contribute to root cause analysis, resolve operational / equipment discrepancies, create maintenance Work orders, and provide input to the manufacturing and maintenance SOPs. He / She will be responsible to coordinate and resolve specific design, operation, troubleshooting issues with the Project Team, Quality Validation, Safety / Health / Environmental, Facility & Engineering, Maintenance, and Manufacturing groups.
- Demonstrates competence in understanding quantitative and qualitative process engineering principles and concepts with an ability to provide solutions to complex technical problems in the bio-pharmaceutical processing.
- Operational competence of Upstream systems related manufacturing steps, and good understanding of complete Mammalian Cell Culture Upstream Process with particular emphasis on the Harvest systems.
- Strong knowledge of the Automation architecture and hardware / software requirement development
- Cross-knowledge of Cell Culture Process Downstream and Process Supports (e.g. CIP/SIP, Parts Washers/Autoclaves) is desirable.
- Good understanding of the applicable codes and guidelines (e.g. ASME / ASME-BPE )
- Capable of providing creative, out of the box approaches to design and operating challenges.
- Good understanding of Project Management concepts and execution phases / deliverables for each phase.
- Working knowledge of applicable Quality Systems (e.g. Clean Utilities, sampling /QC).
- Working knowledge of cGMP practices, experience of working in a cGMP environment.
- Bachelor Degree in Chemical or Bio-Chemical Engineering is preferred. Degrees in Mechanical and Nuclear Engineering or equivalent operating experience coupled with Bachelor of Science in relevant scientific disciplines is considered.
- 8-12 years of design and/or operational experience related to Large Scale Biopharmaceutical Upstream processing with particular emphasis on CIP systems and SIP. Commercial Disc Stack Harvest Centrifuge and Depth Filtration operating experience is desirable