Equipment Maintenance at Fusion Life Sciences Technologies LLC

Job Description

Let’s do this. Let’s change the world. In this role, you will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, repairs, and modifications. You will evaluate and determine if process equipment maintenance and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area.

Responsibilities:

Take part in the coordination of tech support on engineering, regulatory, compliance, quality, microbial/environmental, technical cleaning, validation, and mechanical, electrical and process automation issues.

Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.

Complete maintenance activities or operate and monitor plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans and Amgen policies.

Investigate issues or problems through the mentorship of experienced staff.

Assist with maintaining an up-to-date working spare parts inventory system for the equipment/systems.

Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program, and troubleshoot and repair equipment/system failures.

Interpret and review utility, process system/equipment, plumbing, ductwork plans, architectural, and P&IDs.

Support Operations in non-standard shifts that include weekends and/or holidays as determined by business.

Ability to work night shift

What do we expect of you?

We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek will possess these qualifications.

Basic Qualifications:

High school/GED + 2 years of Technical Engineering experience

Or

Associate’s + 6 months of Technical Engineering experience

Or Bachelor’s

Preferred Qualifications:

Educational background in Mechanical Engineering, Mechatronics, or related technical degree

Experience repairing mechanical equipment in a manufacturing environment (experience with packaging equipment preferred)

Strong mechanical proficiency and troubleshooting skills

Understanding in PLC, Computer Serialization, Packaging Equipment, Vision Inspection Systems (Cognex Vision System and Systech Serialization)

Excellent organizational, project management, problem-solving and technical writing capability

Strong communication: verbal / written, collaboration, influencing and facilitation

MS Office: Word, Excel, PowerPoint