Equipment Engineer

GenScript/ProBio•Redmond, WA

2d•Onsite

About The Position

This Equipment Engineer reports to the Equipment Manager based in New Jersey and is critical for providing onsite equipment engineering leadership at our Redmond, WA facility. The ideal candidate is a highly organized and independent professional with strong communication skills, experienced in managing the full lifecycle of laboratory and production equipment. This role requires taking full ownership of equipment-related events in Redmond, with strategic support from the NJ-based team. The primary initial focus will be on managing the site's calibration and preventive maintenance program by scheduling and overseeing third-party vendors. The engineer will ensure equipment reliability and compliance within a GMP/ISO framework through effective asset management and vendor coordination.

Requirements

Bachelor’s degree in Engineering or a related scientific field.
3+ years of experience in an equipment engineering, maintenance, or calibration role within a biotech, pharmaceutical, or medical device environment.
Proven experience scheduling, managing, and overseeing third-party service vendors for calibration and preventive maintenance.
Strong experience managing assets and work orders within a CMMS (e.g., Limble, Maximo, Blue Mountain).
Familiarity with GMP and ISO quality standards is required.
Excellent organizational skills and the ability to manage multiple priorities and vendor schedules independently.
Strong verbal and written communication skills are essential for effective remote collaboration and vendor management.

Responsibilities

Own the site's calibration and preventive maintenance (PM) program by scheduling, coordinating, and overseeing third-party vendors and service contractors.
Serve as the primary point of contact for external vendors; audit their work on-site to ensure quality and compliance.
Manage the spare parts strategy and inventory.
Administer the Computerized Maintenance Management System (CMMS - e.g., Limble) to schedule vendor services, manage work orders, and maintain accurate asset histories.
Maintain and update the site's equipment inventory database, which includes a range of critical instruments such as analyzers, liquid handlers, HPLC systems, spectrophotometers, synthesizers, thermal cyclers, and general lab equipment.
Develop, review, and improve technical Standard Operating Procedures (SOPs) related to equipment operation and maintenance.
Act as the first point of contact for equipment issues, performing initial troubleshooting and coordinating with vendors for advanced repairs as needed.
Lead root cause analysis (RCA) for equipment deviations and implement effective Corrective and Preventive Actions (CAPA).
Progressively build in-house capabilities to perform hands-on PM and calibration activities.
Ensure all equipment activities comply with GMP, ISO, and other relevant regulatory standards.
Support Quality Assurance and Control objectives by ensuring equipment is maintained in a validated state.
Manage documentation for equipment maintenance, vendor service reports, and deviations.
Communicate effectively with site staff, management, and the remote NJ equipment team on equipment status, vendor performance, and projects.
Work autonomously while seamlessly integrating with Redmond stakeholders.