Senior Project Engineer

Fresenius Kabi USA; Wilson (NC); On-site; USD 132,000 - 133,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life Insurance

Disability insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi USA in Wilson, NC is seeking a Mechanical/Manufacturing/Process Engineer to lead projects around terminal sterilized, PVC-free IV bag technology (freeflex). You will coordinate the site operations, facilities and engineering teams, supervise equipment installation, supplier coordination, scheduling, start-up and training of personnel.

Responsibilities include analyzing processes for impact on product quality and yield, conducting risk assessments, and documenting investigations.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, or Process Engineering (foreign education accepted).
• Five years of experience in validated manufacturing of terminal sterilized PVC-free IV bag materials.
• Experience collaborating with engineering, quality, operations and maintenance teams.
• Experience qualifying processes, equipment, and systems in a cGMP environment.

Responsibilities

• Manage implementation of projects for freeflex bag technology in manufacturing.
• Coordinate site operations, facilities and engineering teams in learning new technology systems.
• Install and site modifications, procure equipment and services, schedule, rig, set-up and start-up.
• Analyze processes and identify improvements to quality and yield.
• Prepare technical investigations, root-cause analysis and corrective actions.
• Support risk assessments, validation activities, and QA/QC interfaces.

Education

Bachelor’s degree in Mechanical/Electrical/Manufacturing/Process Engineering

Job description

Job Summary

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.

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.

Requirements

Must have a Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, or Process Engineering (will accept foreign education equivalent) and five (5) years of experience in the validated manufacturing of terminal sterilized pharmaceutical PVC free bags process in a cGMP environment. Position requires: 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.

Salary

$131,807.04 to $133,442.05 per year

Job location

5200 Corporate Pkwy, Wilson, NC 27893

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.