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This position of Industrial Operations Senior Process Engineer, in the Manufacturing Technology (Mtech) function of Industrial Operations, is to support manufacturing toward industrial excellence to guarantee the accuracy, conformity and competitiveness of the processes and techniques utilized for the production of the vaccines and biologics manufactured at the Client industrial sites.
The mission of MTech is to deliver robust and efficient process & testing with associated know-how transfer to Manufacturing & Quality Control (QC).
Mtech’s function also provides daily support, for manufacturing and QC, toward industrial performance excellence.
Develops and manages all single use and multi-use system process designs associated with the specific projects. This includes but is not limited to:
Develop details required for product process system Basis of Design (URS’s, Process Flow Diagrams (PFDs) and Process Descriptions)
Responsible for the design of single use systems and/or select multi-use systems based on product process requirements (interface with product process owners)
Assist in execution of functional testing (C&Q of fixed and single use), including the review/approval of test plans, data packs and reports
Support project teams in their selection of single use and multi-use systems, including supplier capabilities, shop drawing reviews,etc.
Accountabilities: (What the position is to deliver (not how))
Responsible for process design and continuous improvements, including:
o URSs, Design of Single Use Systems, Process Flow Diagrams, Process Narratives
◦ Identifying multi-use equipment
Author and approved protocol and reports supporting execution of functional testing
Comply with cGMP and other internal and external quality and regulatory guidance and health and safety guidelines
The Job Responsibilities Include: (Responsibilities = How to deliver)
Input to design space / DOE studies through establishment of scale-up / scale-down parameters utilizing engineering fundamentals (mixing, mass / heat transfer, modeling, dimensionless parameters, etc.) and process control strategies.
Partner with Engineering to ensure industrial implementation of process design, including review of engineering design documents, provide review and input to C&Q strategy and participating in testing of equipment
Provide technical assistance to manufacturing technology for process troubleshooting.
Education and experience:
BS in Engineering (chemical, biochemical, mechanical or similar) with a minimum of 7 years industrial experience.
Expertise in process equipment design and implementation, including disposables
Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed in the course of industrial process design, validation and control.
Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
Experience in equipment start-up, qualification is preferred.
Proficient in MS Office 365 software
Proficient in communication tools- Outlook and Zoom
Proficient in a cGMP documentation system preferably GEODE.
process design, Quality by Design, Design Space, Process Control, validation and control, root cause analysis, cGMP
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