Maintenance & Validation Technician

General Summary and Purpose:

The Maintenance and Validation Technician’s primary function of this role is to support cleanroom, laboratory and

building services including equipment and facility and equipment lifecycle maintenance, vendor coordination, and

equipment sourcing/on-boarding/commissioning in accordance with Standard Operating Procedures, Quality

Management System and Policies and timeline requirements.

Duties and Responsibilities:

• Oversees maintenance of equipment records system to support the GMP compliant cleanrooms and

laboratories

• Initiates, authors, and reviews equipment Standard Operating Procedures (SOP)

• Schedules equipment service calls and regular calibrations performed by external service providers

• Oversees and verifies that external service providers perform maintenance in line with internal and

regulatory requirements

• Interfaces with manufacturing/QC/logistics staff to schedule and perform equipment maintenance

• Performs equipment relocations

• Performs equipment installations, required calibrations, and routine maintenance

• Troubleshoots emergent equipment issues to prevent delays to in-progress production

• Performs equipment repairs or facilitates repair by an external service provider

• Performs sourcing, on-boarding, and commissioning of equipment in conjunction with departmental SMEs

• Develops, authors, and oversees execution of equipment and facilities qualifications (IQ/OQ/PQ)

• Authors deviation investigations and executes CAPA plans

• On call after hours to respond to equipment monitoring system alarms

Other Duties

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.

Reporting Relationships:

This position reports to Building and Facilities Manager, BioLife Solutions, Bothell, WA

Job Requirements:

1-2 years cGMP facility engineering/equipment lifecycle management experience

1-2 years equipment validation experience

Detail oriented

Strong written and oral communication skills

Organizational and multi-tasking skills

Results driven

Skilled at technical troubleshooting

Job Specifications:

BioLife Solutions provides a substance-free workplace, and all offers of employment will be contingent on opiate drug test and background check.

BioLife Solutions is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.