Sr. Project Engineer, IT

Job SummaryResponsible for specifying and procuring new equipment and tooling. Responsible for designing new equipment and modifications to existing equipment, manage equipment and facilities projects from conception through completion, determine change control requirements and follow through on pre-approval requirements, prepare and execute validation protocols. Excellent written and verbal communication skills. Excellent project management, including experience using MS Project. Experienced AutoCAD operator. Maintain cGMP and EU compliance.
Salary Range: $84,407-$122,389 annually + 6% annual bonus
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Responsibilities

• Develops and manages site projects by employing past experience, research, design and concept sketches, layouts, drawings, vendor interaction, preparation of specifications, discussions with appropriate management and site personnel.
• Leads and develops 1 to 2 direct reports.
• Prepares, writes and executes Risk Analysis (FMEA, Fishbone Diagrams) and Critical Change Requests.
• Prepares and executes User Requirement Specifications, Functional Requirement Specifications, Design Specifications/Qualifications, Factory and Site Acceptance Tests, Machinability Studies and Standard Operating Procedures as necessary for new and modified equipment.
• Prepares funding requests per corporate guidelines, including detailed project descriptions, backgrounds, sketches, alternatives, financial data, justifications, quotations, estimates and schedules.
• Manages and supervises the installation of equipment and/or facility modifications or additions.  Includes vendor selection, procurement of equipment or services, scheduling, vendor coordination, rigging, set-up, start-up, troubleshooting, de-bugging, training and budgeting.
• Prepares and executes validation protocols.
• Assists Manufacturing and Maintenance with solving problems, improving processes and reducing costs.
• Maintain Regulatory, Fresenius Kabi and customer compliance.

Requirements

• Bachelor’s degree and 5 years equivalent experience in a similar discipline required.
• Must have an in-depth engineering background.
• Must be familiar with regulated industry, experienced with machine design and equipment layout design as well as specifying and installing manufacturing equipment.
• This position also requires an in-depth working knowledge of project management and experience using MS Project.
• Must possess a thorough understanding of mechanical, plant systems, as well as the ability to read construct and process drawings.
• This position requires excellent problem solving and communication skills.
• Must be familiar with AutoCAD and/or SolidWorks

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.

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.