Job Summary
Responsible for specifying, procuring and installing new equipment for an aseptic manufacturing facility. Responsible for reviewing designs of new equipment and making modifications to existing equipment. Must manage equipment and facilities projects from conception through completion, determine change control requirements and follow through on pre-approval requirements and support the execution of validation protocols. Excellent written and verbal communication skills. Excellent project management, including experience using MS Project. Experienced in PLC and HMI programming. Must maintain cGMP and EU compliance.
Salary Range: $73,614 - $103,528
Position is eligible to participate in a bonus plan with a target of 6% of the base salary.
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.
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.Includes 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.
- Maintain Regulatory, Fresenius Kabi and customer compliance.
REQUIREMENTS:
- Must have an in depth electrical engineering background.
- Must be familiar with regulated industry
- Experienced with PLC programming (Allen Bradley and/or Siemens) and HMI programming
- This position also requires an in depth working knowledge of project management and experience using MS Project.
- Must possess a thorough understanding of Automation control systems and electrical systems
- This position requires excellent problem solving and communications skills.
- Bachelor degree and 5 years equivalent experience in a similar discipline required.Equivalent related work experience will be considered in lieu of degree.
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.
