Our client is a leader in pharmaceuticals located in Madison, WI . They are in need of a Project Engineer to join their team! The Project Engineer is responsible for providing engineering guidance to complete assigned engineering projects starting with development of project scope through detail designing, funding approval, project completion scheduling, actual completion of construction and/or equipment installation, start-up validation and documentation. They define process and equipment changes to achieve production requirements. They analyze production equipment operations, routine maintenance, and energy requirements of process systems to optimize economical operation and meet regulatory requirements.
• Provide scope, hire, manage, supervise, review and seek authorization of contracts for consulting engineering firms and constructioncontractors to accomplish the actual changes of processes, equipment and facilities.
• Develop design parameters for the manufacture of bulk pharmaceutical products, including equipment and facility specifications.
• Develop funding justification, seek approval and then accomplish and control projects within funding approval.
• Supervise installation, start-up and participate in validation of processing equipment.
• Document performance of processing systems to achieve validation and compliance with QA and other regulatory requirements and agencies.
• Design tests and methods to analyze process conditions to optimize operational efficiencies and/or to meet defined process and product specification.
• Manage the design drafting and documentation department.
• Create and maintain appropriate documentation systems to support regulatory compliance for EPA, DNR, FDA, OSHA, and other regulatory bodies.
- B.S. degree in Engineering (Chemical, Electrical, Mechanical, Reliability) or related field required.
- Must have 10 or more years of relevant experience in pharmaceutical, food products, or chemical industries.
- Experience in design drafting and documentation, design, construction and management of facility expansions and equipment installations.
- Must have strong applications and analytical testing skills and demonstrated knowledge of cost control procedures, data analysis, and manufacturing processes and systems.
- Experience in project management and regulatory compliance is required.