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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
• 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:
  •  2-4 years experience in biotech facility or equipment management
  • Associates Degree in a field of science
  • CMRP certification
  • 1-2 years experience executing equipment validation protocols
  •  Experience with CAPA and Change Control systems
  • Strong written and oral communication skills
  •  Proficient in Microsoft Office

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.