Senior Project Engineer

Fresenius Kabi USA•Wilson, NC

1d•$131,807 - $133,442

About The Position

Manage implementation of projects related to the manufacturing of terminal sterilized pharmaceuticals, specifically bags for intravenous fluids filled in Polypropylene bags, using its unique freeflex® bag technology. Ensure inclusion of existing site operation, facility and engineering team members in the learning process of new technology systems. Manage and supervise the installation of equipment and/or facility modifications or additions to include selecting and coordinating suppliers, procuring equipment and services, scheduling, rigging, set-up, start-up, troubleshooting, de-bugging, training and budgeting. Develop and manage site projects by employing experience, research, design and concept sketches, layouts, drawings, supplier interaction, preparation of specifications, and discussions with appropriate management and site personnel. Analyze the overall process sequences beyond individual equipment and impact on product quality. Analyze production and process issues and initiate activities to resolve them. Develop and train product and process knowledge in our unique freeflex ® bag technology area. Prepare and maintain process technical investigative reports for knowledge management. Identify, promote, and support the operation team on tasks and projects to improve product quality and yield. Design evaluation studies and analysis of manufacturing equipment and systems, collect data, interpret and report writing with supervisor guidance. Identify variances to assist in developing strategies to improve process performance and reduce costs. Promote strategies for efficient improvements to operations. Support the implementation of organization process improvement initiatives and evaluate results. Investigate deviations from standards of manufacturing process using effective root cause analysis tools. Recommend effective corrective and preventative actions to the operations team and support implementation if required. Analyze Critical Process Parameters (CPPs) and other process conditions needed to reliably manufacture products which consistently meet their Critical Quality Attributes (CQAs). Participate in risk assessments and validation activities. Maintain the interfaces with support functions (including QA, QC, and Engineering Services) and the production function to ensure availability of equipment and continuous improvement of the process. Assist with fundamental operation and equipment functionality training as appropriate, specifically related to the unique freeflex ® bag technology system. Set up and maintain process instruction for training and troubleshooting purposes.

Requirements

Must have a Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, or Process Engineering (will accept foreign education equivalent)
five (5) years of experience in the validated manufacturing of terminal sterilized pharmaceutical PVC free bags process in a cGMP environment.
Experience analyzing manufacturing of terminal sterilized pharmaceuticals inside polypropylene bags, using PVC free IV bag material technology and manufacturing process.
Experience qualifying processes, equipment, and systems, including terminal sterilization and product integrity assurance.
Experience collaborating with engineering, quality, operations, and maintenance teams to implement, train and operate the unique PVC free IV bag material technology and manufacturing process.
Experience interpreting production data, identifying deviations, and applying methodologies to problem solving.

Responsibilities

Manage implementation of projects related to the manufacturing of terminal sterilized pharmaceuticals, specifically bags for intravenous fluids filled in Polypropylene bags, using its unique freeflex® bag technology.
Ensure inclusion of existing site operation, facility and engineering team members in the learning process of new technology systems.
Manage and supervise the installation of equipment and/or facility modifications or additions to include selecting and coordinating suppliers, procuring equipment and services, scheduling, rigging, set-up, start-up, troubleshooting, de-bugging, training and budgeting.
Develop and manage site projects by employing experience, research, design and concept sketches, layouts, drawings, supplier interaction, preparation of specifications, and discussions with appropriate management and site personnel.
Analyze the overall process sequences beyond individual equipment and impact on product quality.
Analyze production and process issues and initiate activities to resolve them.
Develop and train product and process knowledge in our unique freeflex ® bag technology area.
Prepare and maintain process technical investigative reports for knowledge management.
Identify, promote, and support the operation team on tasks and projects to improve product quality and yield.
Design evaluation studies and analysis of manufacturing equipment and systems, collect data, interpret and report writing with supervisor guidance.
Identify variances to assist in developing strategies to improve process performance and reduce costs.
Promote strategies for efficient improvements to operations.
Support the implementation of organization process improvement initiatives and evaluate results.
Investigate deviations from standards of manufacturing process using effective root cause analysis tools.
Recommend effective corrective and preventative actions to the operations team and support implementation if required.
Analyze Critical Process Parameters (CPPs) and other process conditions needed to reliably manufacture products which consistently meet their Critical Quality Attributes (CQAs).
Participate in risk assessments and validation activities.
Maintain the interfaces with support functions (including QA, QC, and Engineering Services) and the production function to ensure availability of equipment and continuous improvement of the process.
Assist with fundamental operation and equipment functionality training as appropriate, specifically related to the unique freeflex ® bag technology system.
Set up and maintain process instruction for training and troubleshooting purposes.