9318 Upstream Bioreactor Manufacturing Engineer
Provides technical leadership support to Upstream Manufacturing, take lead in coordinating the automation and mechanical design, operational, and troubleshooting activities.
Coordinate the design activity within the Upstream Project team, Manufacturing, Quality Validation, SHE, Maintenance and Engineering Applies technical knowledge of process, mechanical/physical, instrumentation, thermal and hydraulic design and materials selection critical to the operational performance, availability, mechanical / structural / electrical integrity and reliability.
Support Project Automation design/implementation with updates to Functional Specifications and Functional Design Specification for Upstream CIP systems, Scale-up and Commercial Bioreactors, and associated interfaces with Harvest and Media systems.
Lead operational / equipment discrepancy assessments and investigations related to Quality and Safety. Lead and support Root Cause Analysis.
Implement engineering projects of various magnitude in order to increase levels of safety and/or compliance, improve process and equipment robustness, or increase capacity/productivity/efficiency.
Coordinates Upstream area related Bills of Materials, critical spare parts with Facility & Engineering group.
Provide technical knowledge related to the Bioreactor Systems and associated components continuous improvements.
Coordinates, extracts, and interprets process and equipment operational data obtained from the Batch Historian, through field observations, or compilation of study data, communicating the results to other groups and management.
Develops operational and maintenance SOPs and technical training materials.
Ensures the correctness of the Automation software existing subroutines, code updates and execution as it relates to the Upstream System Classes. Coordinates all technical solutions on operability and functionality with Automation group.
Responsible to correct and review project critical documentation (e.g. specifications, data sheets, calculations, P&IDs / PFDs, Vendor Drawings and Turn-over Packages) that may affect the Upstream Classes performance and integrity.
Participates in the Enhanced Design Review Meetings, Design Qualification reviews, ensures that Traceability Matrices are correct and reflective of the User Requirements.
Contributes to Projects’ estimate, scope definition, and schedule, and adheres to established project timelines for review and approval cycles.
Assists in preparations and execution of the Automation system Commissioning and Qualification protocols.
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.
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.
Excellent written, verbal, and presentation skills with proven ability to use market available software.
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 Bioreactor operating experience is desirable.