Tunnell Consulting Inc. Process Engineer in West Lafayette, Indiana
Job City: West Lafayette
Job State: US - Indiana
Client Project Number: 8990
This position is to support manufacturing toward industrial excellence to guarantee the accuracy, conformity and competitiveness of the processes and techniques utilized for the production of solid dosages manufactured at the industrial sites. The mission is to deliver robust and efficient process & testing with associated know-how transfer to Manufacturing & Quality Control (QC). The function also provides daily support for manufacturing and QC, toward industrial performance excellence.
This position will conduct and optimize activities in area of specialization with high technical and scientific complexity. Through having a high level of expertise and understanding of the design, control and operation of process unit operations typical of pharmaceutical manufacturing, the individual in this position will work with a cross-functional team from various functions to: develop the process design basis (including mass balance, sizing and selection of equipment and instrumentation for control of robust processes), creation of key deliverables such as URS, and provide input to industrialization strategies and rationale for critical process parameters. This role will also serve as Subject Matter Expert (SME) for the applied process design (equipment) development and validation, health authority inspections, and investigations. The individual in this position will work with a cross-functional team from various functions to deliver the following:
· Responsible for process design and continuous improvements of solid dosage manufacturing processes within your respective area of expertise
· Support execution and documentation of development and/or validation studies and lead or supervise groups and/task force in the planning of engineering, investigational, definition and process validation runs.
· Document and interpret study results with recommendations
· Provide technical leadership as a subject matter expert in area of responsibility
· Assist or lead the development and execution of training programs for appropriate audiences
· Comply with cGMP and other internal and external quality and regulatory guidance and health and safety guidelines.
Provide technical leadership, including project team leadership, within area of expertise
The Job Responsibilities Include:
· 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 participate in testing of equipment.
· Participate in life-cycle design, tech transfer and industrialization of solid dosage manufacturing processes and associated test methods for Phase 3 products to assure commercialization of robust, compliant, and efficient processes and test methods for pharmaceuticals.
· 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 as basis for tech transfer of product processes.
· Provide technical assistance to manufacturing and quality operations for process troubleshooting.
· Expertise in solid dosages
· 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 and validation is required.
· Knowledge of computer software common to mission (AutoCAD, process simulation / scheduling, CFD) is preferred.
· Innovation, solidarity, confidence, respect, and integrity and our ways of working (Focus, Agility, Accountability and Simplicity).
· MS Office including Excel, Work, Outlook, Powerpoint
· BS or Advanced degree in sciences with 2-5 year’s large scale process equipment design, scale-up implementation, technology transfer & validation experience.