Sr. CSV Validation Engineer

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
• Strong 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, vested immediately
• 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.