Senior Project Engineer

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

Benefits offered by this job

Medical, dental and vision coverage

401K with company contribution

Wellness program

Job summary

Fresenius Kabi USA, LLC in Wilson, NC is seeking a Manufacturing Project Engineer to lead projects for terminal sterilized IV bag manufacturing using Freeflex technology. You will coordinate equipment installation, qualification, training and process improvements with QA, QC and Engineering Services.

Requires a Bachelor's degree in Mechanical, Electrical, Manufacturing or Process Engineering and five years' experience in validated pharmaceutical manufacturing in a cGMP environment, with strong

Qualifications

• Experience analyzing manufacturing processes in validated pharma environments.
• Ability to interpret production data and identify deviations.
• Experience applying root cause analysis tools to manufacturing problems.
• Collaborates with engineering, QA, QC, operations and maintenance teams.
• Develops and trains knowledge in specialized bag technology.

Responsibilities

• Manage projects related to terminal sterilized pharmaceutical PVC free bag production.
• Coordinate installation, qualification, start-up, debugging, training and budgeting of equipment.
• Develop process knowledge and create specifications, layouts and drawings.
• Analyze process sequences and CPPs/CQAs to ensure product quality and yield.
• Implement process improvements and risk assessments with cross-functional teams.

Skills

Root cause analysis

Data interpretation

Problem solving

Cross-functional collaboration

Training and knowledge transfer

Education

Bachelor's in Mechanical Engineering

Bachelor's in Electrical Engineering

Bachelor's in Manufacturing Engineering

Bachelor's in Process Engineering

Job description

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

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, andwellness program.

Employment Terms

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, 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.

Equal Opportunity Statement

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.