Maintenance Engineer

Overview

Bio Life Solutions is repeatedly named one of Washington’s 100 Best Companies to Work For, a list curated by Seattle Business Magazine. We welcome you to apply to join our dynamic, high-energy team. Here you will find a performance-based, family-oriented environment where authentic communication and treating colleagues with respect are required. Our employees receive a competitive benefits package, which includes a 401k matching program.

Bio Life Solutions is a leading developer, manufacturer and supplier of class-defining cell and gene therapy bioproduction tools and services. Our solutions facilitate basic and applied research and commercialization of new therapies by maintaining the health of biologic source material and finished products during manufacturing, storage, and distribution. Our solutions offer commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of biologic materials.

Our tools portfolio includes our proprietary, serum-free and protein-free, fully defined Cryo Stor 00 freeze media and Hypo Thermosol ae shipping and storage media, ThawSTAR ae family of automated, water-free thawing products. For more information, please visit:

The Maintenance Engineer is a core team member of the Facility and Equipment Operations (FAC) team. The Maintenance Engineer role will support day-to-day tasks and ongoing projects to make Bio Life Solutions and their business successful. Some of the key traits, but not limited to are:
Assisting with ongoing projects, Supporting Bio Life internal & external customers, and constantly improving the FAC team. The role will perform all functions in compliance with Company Policies and Quality Systems.

• Leads/Oversees maintenance of equipment records system to support the GMP compliant clean rooms and laboratories.
• Revises equipment SOP
• Schedules equipment service calls and regular calibrations performed by external service providers.
• Assist/Lead/Drive Cleanroom maintenance programs in accordance with our internal customers.
• Assist/Lead/Drive FAC department mini projects in accordance with stakeholders and desired outcome.
• Oversees and verifies that external service providers perform maintenance in line with internal and regulatory requirements.
• Support site service activities and requests. By providing service and documenting actions and updating team members.
• Interfaces with manufacturing/QC/logistics staff to schedule and perform equipment maintenance.
• Performs equipment relocations and Final Acceptance Test (FAT) of more complicated equipment.
• Performs equipment installations, required calibrations, and routine maintenance.
• Troubleshoots, track, and document to resolution emergent equipment issues to prevent delays to in-progress production.
• Performs equipment repairs or facilitates repair by an external service provider.
• Write or revise equipment and facilities qualification documents (IQ/OQ/PQ)
• Perform or oversees execution of equipment and facilities qualifications (IQ/OQ/PQ)
• Author QMS investigations and design of CAPA plans
• Implement CAPA plans.
• Track, trend, and analyze department metrics and KPIs. Propose continuous improvement projects based on analyzing department data.
• Conducts sourcing, on-boarding, and commissioning of equipment in conjunction with head of Facilities and departmental SMEs.
• Must be able to support off hours; evenings and weekends when tasks dictate the need.
• Assists in training and oversight of Maintenance and Validation Technician I & II team members.
• On call after hours to respond to equipment monitoring system alarms.
• Cross train with all Bio Life platforms production and servicing.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

• Able to lead projects independently. Be able to translate trouble shooting into standard work.
• Detail oriented.
• Strong written and verbal…