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 TitleSenior Computer System Validation Engineer (Gene Therapy Program)Job Profile TitleValidation Engineer III SeniorJob Description SummaryThe 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, StateKing of Prussia, PennsylvaniaDepartment / SchoolPerelman School of MedicinePay Range$81,358.00 – $100,000.00 Annual RateSalary 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
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay
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