Sr. Maintenance Engineering Technician; Onsite

Position: Sr. Maintenance Engineering Technician (Onsite)
POSITION SUMMARY

The Senior Maintenance Engineering Technician is a highly skilled, self-directed technical contributor responsible for the installation, troubleshooting, and preventive/corrective maintenance of site-wide equipment supporting operations across cGMP manufacturing, non-GMP facilities, and laboratory environments. This onsite position reports to the Maintenance Manager within the Engineering department at the Northpointe facility in Lynnwood, WA-a commercial-scale cGMP manufacturing site producing Leukine® (sargramostim), a therapeutic glycoprotein.

PRIMARY RESPONSIBILITIES

• Collaborates across functions and with customers to support maintenance, projects, and continuous improvement across asset lifecycle.
• Ensures cGMP compliance through accurate documentation of equipment operations and maintenance using AMS and related systems.
• Maintains, operates, and optimizes critical and non-critical utility systems (HVAC, controls, refrigeration, emergency power, electrical distribution, compressed air, medical gases, purified/WFI water, wastewater, and steam systems) in cGMP environments.
• Plans, schedules, and oversees inspections, testing, maintenance, and contractor work to ensure compliance, documentation, and on-time completion.
• Performs all maintenance and repairs in accordance with cGMP procedures, validation requirements, change control, and regulatory expectations.
• Complies with SOPs, cGMP regulations, safety standards, OSHA/WISHA requirements, company policies, and applicable laws.
• Proactively identifies inefficiencies and implements improvements to enhance reliability, performance, and operational effectiveness.
• Interprets drawings, schematics, and technical specifications to support maintenance and repair activities.
• Executes preventive and corrective maintenance on cGMP process equipment, including vessels, mixers, chromatography systems, autoclaves, washers, pumps, and valves, in cleanroom environments.
• Performs gowning and PPE procedures as required by cleanroom standards.
• Participates in facility inspections, log entries, and required safety, quality, and compliance training.
• Performs other assigned duties as needed.

KNOWLEDGE, SKILLS, ABILITIES

Required:

• Experienced strong senior-level technical proficiency, including:
• Advanced troubleshooting skills using structured diagnostics to resolve complex equipment, utility, and system issues.
• Strong preventive and corrective maintenance experience across industrial, process, and laboratory equipment, including failure mode analysis.
• Expert knowledge of safety programs and regulatory requirements, including LOTO and other critical procedures.
• Proficient with Asset Management Systems (e.g., Maximo, BMRAM) for work orders, asset history, and data accuracy.
• Participates in rotational on-call support, providing after-hours response to maintenance and facility emergencies.
• Develops and maintains SOPs and job plans, ensuring clarity, accuracy, and cGMP compliance.
• Advanced proficiency in Microsoft Word, Excel, and Outlook; quick to adopt new applications.
• Works effectively both independently and in cross-functional teams, demonstrating accountability and initiative.
• Strong interpersonal skills, adaptability, and openness to feedback in dynamic environments.
• Clear written and verbal English communication, including technical discussion and recommendations.
• Experience supporting root cause analysis (RCA), CAPAs, and change control processes.

Preferred:

• Advanced technical knowledge and practical experience in any of the following areas:
• Expertise in cleanroom HVAC operation, performance assessment, fault diagnosis, and efficiency optimization.
• Strong understanding of heat transfer and fluid flow as applied to process equipment and utility systems.
• Knowledge of pump and valve technologies, including operation, performance, and failure analysis.
• Experience with regulated water systems (RO/DI, distillation, WFI), including operation and maintenance.
• Proficiency with plant and clean steam generation and distribution systems.
• Mechanical and electrical troubleshooting across integrated utility and process systems.
• Familiarity with PLCs and VFDs, including control logic…