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Fresenius Kabi · 6 days ago

Manufacturing Engineer

Grand Island, NY

Full-time

Onsite

Entry Level

$61K/yr - $86K/yr

1+ years exp

Fresenius Kabi is a healthcare company that specializes in the development and manufacturing of high-quality pharmaceutical products. They are seeking a Manufacturing Engineer responsible for engineering project execution focused on improving plant performance, capacity, and quality through design modifications and equipment procurement. The role also involves managing projects from conception to completion while ensuring compliance with regulatory standards.

BiotechnologyHealth CarePharmaceutical

H1B Sponsor Likely

Responsibilities

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

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

Oversees 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

Responsible for maintaining automated and controlled systems for manufacturing equipment

Rotating on-call availability for off-shift hours for manufacturing support

Qualification

High-speed manufacturing machineryAutoCADSolidWorksProject managementCGMP complianceComputerized control systemsMechanical systemsFDA regulationsCommunicationProblem solving

Required

Bachelor degree and 1-3 years' experience in a similar discipline

Must have excellent problem solving and communications skills

Must have an engineering/technical background

Preferred

Experience with high-speed manufacturing machinery design and operation

Working knowledge of project management and experience using MS Project

Understanding of plant mechanical and electrical systems, as well as the ability to read construction and process drawings

Experience with AutoCAD and/or SolidWorks

Computerized and automation control system familiarity

Familiarity with FDA or other regulated industry

Benefits

401(k) plan with company contributions

Paid vacation

Holiday and personal days

Employee assistance program

Health benefits to include medical, prescription drug, dental and vision coverage

Life insurance

Disability

Wellness program

Company

Fresenius Kabi

Glassdoor3.9

Fresenius Kabi is a health care company, that offers therapy and care of chronically seriously ill people - in and out of hospitals.

Founded in 1999

Bad Homburg, Hessen, DEU

10001+ employees

https://www.fresenius-kabi.se

H1B Sponsorship

Fresenius Kabi has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (14)

2024 (17)

2023 (17)

2022 (15)

2021 (14)

2020 (22)