BioLife Solutions, Inc. · 1 day ago
Maintenance Engineer
Bothell, WA
Full-time
Onsite
Mid, Senior Level
$76K/yr - $106K/yr
5+ years expBioLife Solutions is a leading developer, manufacturer and supplier of class-defining cell and gene therapy bioproduction tools and services. The Maintenance Engineer will support day-to-day tasks and ongoing projects to ensure the success of BioLife Solutions by overseeing maintenance of equipment, assisting with cleanroom maintenance programs, and driving continuous improvement initiatives.
Biotechnology
Responsibilities
Leads/Oversees maintenance of equipment records system to support the GMP compliant cleanrooms and laboratories
Revises equipment Standard Operating Procedures (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 BioLife platforms production and servicing
Qualification
Required
Able to lead projects independently. Be able to translate trouble shooting into standard work
Detail oriented
Strong written and verbal communication skills
Organizational and multi-tasking skills
Results driven and adaptable to irregular non-frequent events
Strong technical/troubleshooting skills
Positive attitude, flexibility, and willingness to learn and work in a team environment
5+ years cGMP facility or equipment lifecycle management experience required
Must be able to lift up to 55 pounds at a time
Preferred
Cleanroom experience preferred, but not mandatory
2 years equipment validation experience preferred
Experience with working on projects and meeting deadlines for the success of the overall team
Experience with creating and updating product build work instructions (WI)
NPI experience a plus
CMRP certification a plus
Experience with CAPA and Change Control systems and management
Proficient in Microsoft Office
Benefits
401K with generous match
Medical
Dental
Vision
Life and disability insurance
Vacation and Sick time
Cash bonus or stock equity grants based on company performance
Company
BioLife Solutions, Inc.
Preserving the Promise™ The human body can heal itself.
201-500 employees
H1B Sponsorship
BioLife Solutions, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2022 (1)
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
Sean Werner
Chief Technology Officer- Cell Processing
Troy Wichterman
Chief Financial Officer
Company data provided by crunchbase