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. This includes qualification of GxP computerized systems for both laboratory and manufacturing based equipment as well as GMP software applications. Key deliverables are preparation of relevant documentation to meet regulatory requirements for new and existing products (Validation Plans, User Requirements Specifications (URS), Risk Assessments, IQ/OQ/PQ protocols and Traceability Matrices). 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.
ESSENTIAL JOB FUNCTIONS
Lead Protocol generation, oversee execution, data analysis, report generation and approval of qualification activities for GMP 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, ISO, Data Integrity guidance, and internal standards
Support investigations into protocol nonconformances and site deviations
Serve as initiator and owner of validation related change controls and corrective and preventative actions
Author standard operating procedures related to CSV validation practices
Support the execution and generation of formal risk assessments
Enhance CSV validation programs
Analyze validation data, identify gaps, and support investigations and corrective actions
Represent CSV during audits and regulatory inspections
SPECIAL WORK REQUIREMENTS
Fully onsite position
S trong communication skills
Familiarity with Microsoft Office, Excel, and Visio
Ability to work well with diverse groups in a matrix -style, growing, safety focused organization
Ability to manage multiple activities
The ability to communicate with fellow project team members
Criminal background check required
Other duties as assigned
EDUCATION/CERTIFCATIONS/LICENSES
A minimum of a Bachelor’s degree in Engineering, Computer
Science or related discipline
Desired
ON-THE-JOB EXPERIENCE
7+ years of Computer System Validation experience
Desired
KNOWLEDGE, SKILLS AND EXPERIENCE
In depth CSV experiences including as a Validation lead
Essential
The ability to communicate with employees of all experience levels from Genezen and other contract firms
Essential
The ability to report on project activity in a clear and concise manner
Essential
The ability to communicate with fellow project team members
Essential
Understanding of cGMP regulations
Essential
Technical writing ability
Essential
Familiarity with Microsoft Office
Essential
Ability to work well with diverse groups in a matrix -style, growing, safety focused organization
Essential
Ability to manage multiple activities with challenging timelines
Essential
In depth knowledge of 21 CFR Part 11, EU GMP Annex 11 and GAMP5 computerized system
Essential
Pay Range:
The annual salary range for this position based upon level hired is: $115,000 - $140,000
Work Environment
Regularly sit for extended periods of time
Movement
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
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
C ommitted to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
U rgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
R esilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
E xecute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.
S olutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.
GENEZEN'S BENEFITS
Paid vacation days, amount based on tenure
Paid sick time
10 observed holidays + 2 floating holiday + 1 volunteer day
401(k) plan with company match up to 6% of salary
Share Appreciation Rights
Choice of several healthcare plans
FSA and HSA programs
Dental & vision care
Employer-paid basic term life/personal accident insurance
Voluntary disability, universal life/personal accident insurance
Accidental Death & Dismemberment (AD&D) Insurance
ADDITIONAL DETAILS
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.