Position may supervise one or more of the following: CAD operator, mechanic, or electrician. Indirectly supervises a cross functional team of internal and external subject matter experts to improve plant performance, capacity and quality.
The primary responsibility of this position is for design modifications to existing high-speed pharmaceutical manufacturing equipment and tooling in order to optimize performance and minimize defects.
This position will also be responsible for specifying and procuring new equipment and tooling, managing equipment and facilities projects from conception through completion, including determining and meeting change control requirements. Excellent written and verbal communication skills. Excellent project management skills including experience using MS Project. Experienced AutoCAD or SolidWorks user. Maintain cGMP compliance in accordance with worldwide guidance sources.
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
- Investigates current equipment performance to identify problems and solutions. Working with operators, quality assurance, and maintenance, identifies and implements necessary improvements. These may include modifications to machine design, tooling, and components.
- May lead and develop 1 to 2 direct reports.
- Prepares, writes and executes Risk Analysis (FMEA, Fishbone Diagrams) and Engineering 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 facility modifications. Performs vendor selection, budgeting, procurement of equipment or services, scheduling, vendor coordination, rigging, set-up, training, start-up, and troubleshooting.
- Prepares and executes validation protocols.
- Assists Manufacturing and Maintenance with solving problems, improving processes and reducing costs.
- Maintains compliance with regulatory agency guidance and Fresenius Kabi procedures.
- Must have an in-depth engineering background.
- Must have experience with Process Piping & Utilities.
- Must have an in depth working knowledge of project management and experience using MS Project.
- Must possess a thorough understanding of plant mechanical and electrical systems, as well as the ability to read construction and process drawings.
- Must have excellent problem solving and communications skills.
- Must be experienced with AutoCAD and/or SolidWorks.
- Familiarity with FDA or other regulated industry preferred.
- Bachelor degree and 5 years experience in a similar discipline required.
How To Apply:
You will be directed to another website for application instructions.