Genezen

Sr. CSV Validation Engineer

Lexington, MA · Senior

Work authorization required$115k-$140kDetected 40 days ago

Data AnalysisExcelClinical TrialsGMPFDA RegulatoryCRISPRCommunicationWritingMicrosoft OfficeGxP

About the role

The incumbent is responsible for leading computerized systems validation projects.
This includes qualification of GxP computerized systems for both laboratory and manufacturing based equipment as well as GMP software applications.
Review and approve qualification documentation on behalf of the validation function

Collaborate with cross functional teams, ensure compliance with regulatory requirements, and drive best‑in‑class validation practices that support our Quality Management System and operational excellence.
Support investigations into protocol nonconformances and site deviations
Support the execution and generation of formal risk assessments
Analyze validation data, identify gaps, and support investigations and corrective actions

The ability to communicate 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 with fellow project team members
Understanding of cGMP regulations
Technical writing ability
Familiarity with Microsoft Office
Ability to work well with diverse groups in a matrix -style, growing, safety focused organization
Ability to manage multiple activities with challenging timelines
In depth knowledge of 21 CFR Part 11, EU GMP Annex 11 and GAMP5 computerized system
S trong communication skills

Regularly sit for extended periods of time
Frequently required to stand; sit; 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
Frequently lift and/or move up to 10 pounds
Rarely lift and/or move up to 25 pounds
Frequently required to communicate by talking, hearing, using telephone and e-mail

Frequently utilize close vision and the ability to adjust focus
Paid vacation days, amount based on tenure
10 observed holidays + 2 floating holiday + 1 volunteer day
Choice of several healthcare plans
FSA and HSA programs
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
Dental & vision care
Voluntary disability, universal life/personal accident insurance

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.
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.
We are dedicated to delivering quality results and upholding ethical principals.
We are committed to being a proactive, collaborative, creative and open-minded partner.

en is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas

This listing is sourced directly from Genezen's careers page and normalized into a canonical job model.