Fresenius - Wilson, NC
posted 6 months ago
About the position
The position is responsible for specifying, procuring, and installing new equipment for an aseptic manufacturing facility. This role involves reviewing designs of new equipment and making modifications to existing equipment. The incumbent must manage equipment and facilities projects from conception through completion, determine change control requirements, and follow through on pre-approval requirements. Additionally, the position supports the execution of validation protocols, ensuring compliance with current Good Manufacturing Practices (cGMP) and European Union (EU) regulations. Excellent written and verbal communication skills are essential, along with strong project management capabilities, including experience using MS Project. The role also requires expertise in PLC and HMI programming, as well as a commitment to maintaining compliance with regulatory standards.
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.
- 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, including vendor selection, procurement of equipment or services, scheduling, vendor coordination, rigging, set-up, start-up, troubleshooting, de-bugging, training and budgeting.
- Assists Operations and Maintenance with solving problems, improving processes and reducing costs.
- Maintains Regulatory, Fresenius Kabi and customer compliance.
Requirements
- In-depth electrical engineering background is required.
- Familiarity with regulated industry is essential.
- Experience with PLC programming (Allen Bradley and/or Siemens) and HMI programming is necessary.
- In-depth working knowledge of project management and experience using MS Project is required.
- Thorough understanding of Automation control systems and electrical systems is needed.
- Excellent problem-solving and communication skills are essential.
- Bachelor's degree and 5 years equivalent experience in a similar discipline required; equivalent related work experience will be considered in lieu of degree.
Benefits
- Medical coverage
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- 401K with company match
- Wellness program
