GMP Equipment Engineer

Merck•Saint Louis, MO

5d•Onsite

About The Position

In this role you will be a strong technical contributor within the Engineering Team supporting manufacturing equipment, maintenance, project engineering, controls and instrumentation, and validation/QA as a SME. The Equipment Engineer must have an in-depth knowledge of process/analytical instrumentation, process controls, and Biopharmaceutical process equipment. The Equipment Engineer also has excellent communication skills, interpersonal skills, technical writing skills, creative problem-solving skills, and has a team-oriented attitude. This position is located at the South Second Street facility.

Requirements

Bachelor’s Degree in Biology, Chemistry, Electrical Engineering, Chemical Engineering, or other Life Science or Engineering discipline and 2+ years of engineering experience.
Associate Degree in Biology, Chemistry, Electrical Engineering, Chemical Engineering, or other Life Science or Engineering discipline and 5+ years of engineering experience.

Nice To Haves

Experience with clean room operations; chromatography, tangential flow filtration, and other purification equipment; isolators, biosafety cabinets, fume hoods, and other protective equipment; or other larger scale chemical or pharmaceutical processing operations.
Experience with Process Analytical Testing equipment.
Experience with lyophilization techniques and equipment.
Experience with process engineering and integration of process equipment into existing manufacturing processes.
Knowledge/understanding of process control systems automation (ie. PLCs, DeltaV process control suite).
Knowledge/understanding of information security/data integrity requirements.
Knowledge/understanding of IT/OT/IoT integration.
Knowledge/understanding of FDA, EU, or other pharmacopeia cGMP regulations.
Able to read and create electrical schematics, P&IDs, instrument loop diagrams, design specification, and validation protocols.

Responsibilities

Responsible for overall asset management of Biopharmaceutical manufacturing equipment including maintenance, calibration, data integrity, system administration, and maintaining the qualified state of validated manufacturing equipment.
Troubleshoot automated control systems, instruments, and process equipment.
Work with Technicians as the Escalation resource for emergency breakdowns and alarms throughout the GMP facilities.
Write, review and/or assist in the development of Manufacturing, Facility and Equipment Operating Procedures
Create User Requirement Specifications, Functional Specifications, and Design Specifications
Supports development of documentation for equipment commissioning, qualification and validation activities related to GMP manufacturing equipment.
Project management, oversight, scheduling, and coordination of capital projects for upgrade or replacement of biopharmaceutical production equipment.