Senior Computer System Validation Engineer (Gene Therapy Program)

University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America’s Best Large Employers in 2023.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

Posted Job Title

Senior Computer System Validation Engineer (Gene Therapy Program)

Job Profile Title

Validation Engineer III Senior

Job Description Summary

The Gene Therapy Program (GTP) is entering a new era of unprecedented opportunity with the great potential to reshape the face of medicine, as we know it. Our discoveries have set the stage for successful treatments and possibly even cures for devastating genetic diseases. GTP is a complex R&D organization consisting of research laboratories supported by multiple core functions which provide internal capacity to perform gene transfer studies from basic research through Phase 1 proof-of-concept human trials.
The laboratory of Dr. Jim Wilson, at GTP of the University of Pennsylvania has been a leader in the development of innovative vector technology for close to three decades. We have emerged as the "go-to" organization for public and private partners, who want to participate in the gene therapy space. Currently we are positioned to lead another round of vector innovation and establish pre-clinical and clinical proof-of-concept in therapeutic applications of in-vivo genome editing.
Continuation of all GTP positions is contingent upon funding.
Due to the needs of our program, we are searching for a Senior Computer System Validation (CSV) Engineer to support the GTP Vector Core analytical and equipment systems. As a Senior Computer System Validation Engineer, you will specialize in the life-cycle management and associated validation of GxP and non-GxP computerized analytical instruments, process development equipment, and enterprise systems at GTP's laboratories located at the Discovery Labs (DL) in King of Prussia, PA and the Translational Research Laboratory (TRL) in University City, PA. The assets to be managed include the computerized systems for general and advanced laboratory instrumentation used to develop, manufacture, and characterize biopharmaceuticals.
The candidate shall have strong knowledge of CSV regulations, methodologies, and documentation necessary to accomplish 21 CFR Part 11 data compliance needs. The candidate shall also have strong knowledge of IT infrastructure and network architecture to integrate computerized systems with an established interdisciplinary IT system at PENN. The candidate will need to collaborate with internal and external stakeholders and creatively determine solutions. The candidate will be the technical point of contact and will liaise with the GTP Quality Assurance team to ensure compliance to appropriate cGxP and computer systems regulation and guidance.
Duties include, but are not limited to, establishing and maintaining the network integration, infrastructure, security, and user authentication/authorization management with an emphasis on data integrity for cloud-native, hybrid-cloud, and LAN computerized systems in compliance to business and regulatory requirements (FDA, EMA, MHRA). The Engineer will troubleshoot, analyze, plan and install software applications for computerized analytical instrument and enterprise systems, including Veeva QualityDocs. The Engineer will develop and implement appropriate technical and procedural controls, complete risk assessments, author/revise SOPs, work instructions, etc. The Engineer will develop and maintain validation plans for computerized laboratory analytical instruments adhering to industry best practices and regulatory requirements. The Engineer will author & execute validation tests, including function, data integrity, and security testing. The Engineer will administer, support, develop, and implement identified data integrity qualification gaps (e.g. backup/business continuity issues) on GxP and non-GxP computer systems.
This position will require you to work on-site during all scheduled working hours and may require some evening/weekend hours as needed to support lab operations. Position will be on call for emergency responses.

Job Description

Qualifications:

• Bachelors degree in Computer Science, Engineering, IT or relevant scientific field required.

• Minimum of 4 years experience supporting computer systems in biotechnology, pharmaceuticals, medical devices, or another regulated industry.

• Demonstrated capabilities in creating validation documentation, including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, IOPQ, Protocols, Reports, Traceability Matrix and SOPs.

• Experience working with systems including (but not limited to) on-premise, cloud, and SAS solutions such as Veeva, LIMS; as well as networks/infrastructure and hardware qualification.

• Knowledge of cGxP’s regulations (e.g. 21 CFR Part 11) and industry guidelines (e.g. GAMP) and how they pertain to laboratory analytical instruments and support equipment.

• Experience with Data Integrity impacts on Validations including Audit Trails.

• Strong organizational drive and skills.

• Excellent written and verbal communication skills.

• Ability to interface with scientists, vendors, and many other groups.

• Advanced IT and/or programming abilities preferred.

Job Location - City, State

King of Prussia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$81,358.00 - $100,000.00 Annual Rate

Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile. 

Affirmative Action Statement 
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

Special Requirements 
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

University Benefits

• Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.

• Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.

• Retirement: Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.

• Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.

• Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you’re newly hired, you won’t have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.

• Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That’s why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.

• Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.

• University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University’s libraries and athletic facilities, or visit our arboretum and art galleries. There’s always something going on at Penn, whether it’s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you’re right in the middle of the excitement—and you and your family can enjoy many of these activities for free.

• Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.

• Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.

• Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.

• Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.

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To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay