Field of studyComputer Science, Engineering (or related)
Study levelBachelor's
Original posting
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 incumbent is responsible for leading computerized systems validation projects and supporting the data integrity program. This includes qualification of GxP computerized systems for both laboratory and manufacturing based equipment as well as GxP software applications. Key deliverables are preparation of relevant documentation (Validation Plans, User Requirements Specifications (URS), Risk Assessments, IQ/OQ/PQ protocols and Traceability Matrices) to meet regulatory requirements for new and existing products. 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
Lead risk-based validation strategies for GxP computerized systems throughout the system lifecycle including protocol generation, oversee execution, data analysis, report generation and approval of qualification activities for GxP software applications
Review and approve qualification documentation on behalf of the validation function
Evaluate, audit, and guide software validation activities to ensure compliance with FDA, EU, ISO, Data Integrity guidances, and internal procedures and standards
Assess the impact of system-related events on the system’s validated state and data reliability.
Lead validation execution and ensure testing is appropriately documented
Support quality events involving CSV in protocol nonconformances, deviations, investigations, CAPAs, and change controls. Serve as initiator and owner of validation related change controls and corrective and preventative actions
Develop, author and improve CSV procedures, templates, standards, and guidance. Monitor industry and regulatory trends and recommend improvements to company practices
Support the execution and generation of formal risk assessments
Support and conduct periodic reviews
Support the evaluation of data lifecycles and data flow from creation through processing, review, approval, reporting, retention, and archival
Support risk-based Data Integrity Assessments and the audit trail review process
Identify data integrity risks and partner with system owners to implement remediation plans
Provide CSV and Data Integrity expertise during vendor selection and qualification. Define expectations for vendor testing, validation documentation, audit trails, electronic signatures, and data retention.
Provide guidance to project teams, system owners, IT, and vendors regarding GxP validation requirements
Promote a strong data integrity culture across GxP functions
Support audits and regulatory inspections in representing CSV, as needed
SPECIAL JOB REQUIREMENTS
Adaptability required as work schedule may change based on business needs
Criminal background check required
Other duties as assigned
EDUCATION / CERTIFICATIONS / LICENSES
A minimum of a bachelor’s degree in Engineering, Computer Science or related discipline
ON-THE-JOB EXPERIENCE
7+ years of Computer System Validation experience
Strong understanding of GxP computerized systems and validation principles with experience leading validation projects for Enterprise, Laboratory, Manufacturing, and Quality Systems.
Demonstrated experience developing and executing risk-based CSV strategies
Experience with computerized system periodic reviews
Experience with audit trail and data integrity assessments
SKILLS / ABILITIES
The ability to communicate effectively with employees of all experience levels from Genezen and other contract firms
The ability to report on project activity in a clear and concise manner
The ability to communicate and work effectively with fellow project team members
Ability to work well with diverse groups in a matrix-style, growing, safety focused organization
Understanding of cGMP regulations
Strong technical writing skills
Strong working knowledge in Microsoft Office (Word, Excel, Visio, etc.) and Adobe Acrobat
Strong project management skills with the ability to manage multiple activities with challenging timelines
Strong working knowledge of 21 CFR Part 11, EU GMP Annex 11, ICH guidelines, GAMP 5 and data integrity guidelines
COMPENSATION RANGE
The anticipated annual salary range for the Sr. Validation CSV positions is $115,000-$140,000. PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands:
Work Environment
Regularly sit for long periods of time.
Movement
Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl
Lifting
Frequently lift and/or move up to 10 pounds
Rarely lift and/or move up to 25 pounds
Vision
Frequently utilize close vision and the ability to adjust focus
Communication
Frequently required to communicate by talking, hearing, using telephone and e-mail
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.
Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
This position requires a criminal background check.
Genezen is an Equal Opportunity Employer.
Genezen participates in EVerify.
Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
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.