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Lexington, Tennessee, United States
Onsite
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.
WORKING AT GENEZEN
Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.
JOB SUMMARY
The Manager/Sr. Manager, Validation - CSV & Data Integrity is responsible for ensuring that computerized systems supporting GxP operations are appropriately assessed, validated, implemented, controlled, and maintained throughout their lifecycle. This includes qualification of GxP computerized systems for both laboratory and manufacturing based equipment as well as GxP software applications. Supports the Data Integrity program to ensure that GxP data is reliable, complete, accurate, attributable, secure, and maintained in accordance with regulatory expectations and company quality standards. Collaborates with cross functional teams, ensuring compliance with regulatory requirements, and drives best‑in‑class validation practices that support our Quality Management System and operational excellence.
JOB RESPONSIBILITIES:
Computer Systems Validation
Data Integrity
Management/Leadership
SPECIAL WORK REQUIREMENTS
Ability to work well with diverse groups in a matrix-style, growing, safety focused organization
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EDUCATION/CERTIFCATIONS/LICENSES |
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Bachelor’s degree in Engineering, Computer Science or related discipline. |
Essential |
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ON-THE-JOB EXPERIENCE |
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10+ years of Computer System Validation experience |
Essential |
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Strong understanding and hands on CSV experience in implementations, upgrades, patches, configuration changes, integrations/interfaces, data migrations, system replacements and retirement/decommissioning projects |
Essential |
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Collaborate and build strong partnerships across QA, QC, Manufacturing, Engineering, IT, Operations, and business functions. |
Essential |
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KNOWLEDGE, SKILLS AND EXPERIENCE |
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Ability to communicate effectively and collaboratively with employees of all experience levels from Genezen, with project team members and other contract firms |
Essential |
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Excellent communication skills (interpersonal, presentation, verbal and written) |
Essential |
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Ability to work well with diverse groups in a matrix-style, growing, safety focused organization |
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Excellent technical writing skills |
Essential |
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Demonstrates good analytical problem-solving skills |
Essential |
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Excellent project management skills |
Essential |
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Strong working knowledge in Microsoft Office (Word, Excel, Visio, etc.) and Adobe Acrobat |
Essential |
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Strong working knowledge of GxP regulations including 21 CFR Parts 11, 210/211, EU GMP Annex 11, data integrity guidances, ICH guidelines, and GAMP 5 best practices with the ability to assess compliance risks |
COMPENSATION RANGE
Work Environment
Movement
Lifting
Vision
Communication
GENEZEN'S CURES VALUE-BASED COMPETENCIES
Committed to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.
Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.
GENEZEN'S BENEFITS
ADDITIONAL DETAILS
Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.
Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.
Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.