GMP Equipment Engineer

About the role

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 Subject Matter Expert (SME). The Equipment Engineer must have an in-depth knowledge of process/analytical instrumentation, process controls, and Biopharmaceutical process equipment. This position is located at the South Second Street facility.

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.
• Support 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.

Requirements

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

Preferred Qualifications

• 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 (e.g., 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.

Pay

Pay range for this position: $78,500 - $117,700 per year. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses.

Benefits

• Health insurance
• Paid time off (PTO)
• Retirement contributions
• Other perquisites

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace.