Job Summary
Responsibilities
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.
Salary Range: $73,614 - $120,000 Annually + 6% Bonus
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
- 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.
- All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.
Requirements
- Bachelor of Science degree in Engineering or related field of study and five (5) years experience.
- Must have an in-depth engineering background.
- Must have experience with high-speed packaging machinery design and operation.
- 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.
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, andwellness 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.
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