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University of Colorado Anschutz

Department: Gates Institute Biomanufacturing Facility

Job Title: Validation Engineer (temporary)

Position#00779113 requisition# 40578

This is a temporary position limited to no more than 9-months. 

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 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

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.

Qualifications:

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.

How to Apply:

For full consideration, please submit the following document(s):

1.    A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position

2.    Curriculum vitae / Resume

3.    Five professional references including name, address, phone number (mobile number if appropriate), and email address

Applications are accepted electronically ONLY at www.cu.edu/cu-careers.

Questions should be directed to: Chris Freedman, christopher.freedman@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues until July 27, 2026.

Anticipated Pay Range:

The hiring range for this position has been established at: $32.00 to $40.00 / hour. 

The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty and training.

Your total compensation goes beyond the number on your paycheck. Temporary employees are only eligible for sick leave benefits. 

Equal 
Employment Opportunity Statement:

The University of Colorado (CU) is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.

ADA Statement:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@ucdenver.edu.

Background Check Statement:

The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.