8430 Process Engineer IV
The Contingent Upstream GMP Services engineer will be reporting to the GMP Services Upstream Manager and will be participating in supporting the Debottlenecking and Automation Upgrade Project.
The responsibility will include the support of the Upstream specific run rate increase design improvements, CIP/SIP functionality, process automation functionality, ensuring that the design complies with safe and quality compliant requirements.
The support engineer will be responsible for ensuring the mechanical design and automation design and functional specifications are reflective of the operational requirements.
The support engineer will review all Upstream systems related project deliverables.
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.
Leadership & People Management:
Provides technical support to the Project Acceptance Lead, assists 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 with updates to Functional Specifications and Functional Design Specification for Upstream CIP systems, Media Prep/Hold, Bioreactors, and Harvest Systems.
Develops Functional Tests for the Automation simulation and on-line GMP environment.
Coordinates Upstream area related Bills of Materials, critical spare parts with Facility & Engineering group.
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.
SPECIFIC FUNCTIONAL AND AUTOMATION TASKS
Develop pin charts associated with equipment phases/procedures, set-ups/break-downs.
Develop and update functional specification.
Configure recipes for upstream equipment.
Perform offline functional testing of sterilization recipes to ensure functional cycles are delivered.
Perform field testing of sterilization cycles.
Perform Cleaning Comparability Assessment (CIP related):
Write technical paper for existing cleaning recipes, outlining critical clean parameters (T-time, A-action, C-concentration, T-temperature) for each equipment’s cleaning cycle.
Trace above parameters to the new automation system cleaning cycle parameters.
Author technical paper outlining the acceptability of the previous cleaning validation to the new cleaning cycle.
Perform offline functional testing of recipes to ensure functionality is delivered.
Perform field testing of cleaning cycles (CIP related).
Perform Sterilization Comparability Assessment:
Write technical paper for existing sterilization recipes, outlining critical parameters (Steam exposure time, Temperature, sterile boundary assessment) for each equipment’s sterilization cycle.
Trace above parameters to the new automation system sterilization cycle parameters.
Author technical paper outlining the acceptability of the previous sterilization validation to the new sterilization cycle.
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.