Validation Engineer (temporary)

University of Colorado•Aurora, CO

2d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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.
Ability to communicate effectively, both in writing and orally.
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.

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 and 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