Validation Engineer (temporary)

Job Summary

The University of Colorado Anschutz is seeking a temporary Validation Engineer to join the Gates Institute Biomanufacturing Facility (GBF) in Aurora, CO. The GBF is an academic Phase I cGMP contract manufacturing facility dedicated to the development and manufacture of novel biologics and cell therapies for early-phase clinical trials and serves as a core capability that differentiates the University in both regenerative medicine and traditional biotechnology.

Within the dynamic environment of the Gates Institute Biomanufacturing Facility, serve as the architect of the site's equipment management program. The Validation Engineer will support the review and release of GMP equipment post calibration, oversee new equipment onboarding including Installation Qualification (IQ), Operation Qualification (OQ), and Process Qualification (PQ), optimize the eQMS equipment management system and surrounding SOPs and paper forms, and monitor metrics to ensure compliance.

Key Responsibilities

• Support Facilities to schedule and coordinate instrument and equipment calibrations and preventative maintenance (PM) activities
• Review and release instrument and equipment post calibration and PM activities
• Oversee the new equipment onboarding process including guiding IQ, OQ, and PQ studies and reports
• Optimize the eQMS asset management system including updating SOPs and paper forms
• Monitor asset compliance, metrics, and effectiveness of the equipment management program

Work Location

Onsite - this role is expected to work onsite and is located in Aurora, CO.

Why Join Us

Join the Gates Institute Biomanufacturing Facility and be part of a team turning cutting-edge science into real therapies for patients. At the GBF, your work directly supports the development and manufacture of novel biologics and cell therapies advancing into early-phase clinical trials, offering a rare opportunity to contribute to life-changing innovation at the intersection of academia and industry.

Minimum Qualifications

• Bachelor's degree in scientific discipline or related field, or an equivalent combination of education and relevant experience
• Minimum of three (3) years of experience administering and maintaining a GMP instrument/equipment program or learning management system within a regulated life sciences environment
• Applicants must meet minimum qualifications at the time of hire

Preferred Qualifications

• Experience developing GMP equipment validation program
• Knowledge of FDA cGMP regulations, FACT standards, and GMP documentation practices
• Experience developing IQ, OQ, and PQ protocols for GMP equipment

Knowledge, Skills and Abilities

• Ability to communicate effectively, both in writing and orally
• Strong English verbal and written communication skills required
• Ability to accurately read, interpret, and produce technical documentation
• Ability to establish and maintain effective working relationships with employees at all levels throughout the institution
• Outstanding customer service skills
• Highly self-motivated and organized, with the ability to work both independently and collaboratively in a fast-paced, team-oriented environment
• Technical writing ability to draft and edit controlled documents such as SOPs, Work Instructions (WIs), and forms

Conditions of Employment

• Strong English verbal and written communication skills required, with the ability to accurately read, interpret, and produce technical documentation

Pay

• $20.00 to $30.00 / hour
• Temporary employees are only eligible for sick leave benefits