Senior Manufacturing Engineer

Fresenius Kabi; Town of Grand Island (NY); On-site; USD 73,000 - 120,000; Full time

Job summary

A leading company in the pharmaceutical manufacturing sector seeks a Human Resources Generalist to manage equipment projects, ensure compliance, and lead direct reports. The ideal candidate will have a Bachelor’s degree and at least 5 years of relevant experience in engineering and project management.

Qualifications

• 5 years' experience in a similar discipline required.
• In-depth engineering background with high-speed packaging machinery experience.
• Knowledge of plant mechanical and electrical systems.

Responsibilities

• Investigates equipment performance and implements improvements.
• Prepares and executes validation protocols.
• Manages equipment installation and facility modifications.

Skills

Project Management

Problem Solving

Communication

cGMP Compliance

Education

Bachelor Degree

Tools

AutoCAD

SolidWorks

MS Project

Job description

This range is provided by Fresenius Kabi. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$73,614.00/yr - $120,000.00/yr

Direct message the job poster from Fresenius Kabi

Human Resources Generalist at Fresenius Kabi

Job Description Summary

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.

Job Description

• 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.

Requirements

• Bachelor degree and 5 years’ experience in a similar discipline required.
• 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Industries

  Pharmaceutical Manufacturing

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