Sr. CSV Validation EngineerLexington, MAThe 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.Job SummaryThe 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 FunctionsLead protocol generation, oversee execution, data analysis, report generation and approval of qualification activities for GMP software applicationsReview and approve qualification documentation on behalf of the validation functionEvaluate, audit, and guide software validation activities to ensure compliance with FDA, ISO, Data Integrity guidance, and internal standardsSupport investigations into protocol nonconformances and site deviationsServe as initiator and owner of validation related change controls and corrective and preventative actionsAuthor standard operating procedures related to CSV validation practicesSupport the execution and generation of formal risk assessmentsEnhance CSV validation programsAnalyze validation data, identify gaps, and support investigations and corrective actionsRepresent CSV during audits and regulatory inspectionsSpecial Work RequirementsFully onsite positionStrong communication skillsFamiliarity with Microsoft Office, Excel, and VisioAbility to work well with diverse groups in a matrix-style, growing, safety focused organizationAbility to manage multiple activitiesThe ability to communicate with fellow project team membersCriminal background check requiredOther duties as assignedEducation/Certifications/LicensesA minimum of a Bachelor's degree in Engineering, Computer Science or related discipline - DesiredOn-the-Job Experience7+ years of Computer System Validation experience - DesiredKnowledge, Skills and ExperienceIn depth CSV experiences including as a Validation lead - EssentialThe ability to communicate with employees of all experience levels from Genezen and other contract firms - EssentialThe ability to report on project activity in a clear and concise manner - EssentialThe ability to communicate with fellow project team members - EssentialUnderstanding of cGMP regulations - EssentialTechnical writing ability - EssentialFamiliarity with Microsoft Office - EssentialAbility to work well with diverse groups in a matrix-style, growing, safety focused organization - EssentialAbility to manage multiple activities with challenging timelines - EssentialIn depth knowledge of 21 CFR Part 11, EU GMP Annex 11 and GAMP5 computerized system - EssentialPay Range: The annual salary range for this position based upon level hired is: $115,000 - $140,000Work EnvironmentRegularly sit for extended periods of timeMovementFrequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and armsOccasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawlLiftingFrequently lift and/or move up to 10 poundsRarely lift and/or move up to 25 poundsVisionFrequently utilize close vision and the ability to adjust focusCommunicationFrequently required to communicate by talking, hearing, using telephone and e-mailGenezen's Cures Value-Based CompetenciesCommitted 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 BenefitsPaid vacation days, amount based on tenurePaid sick time10 observed holidays + 2 floating holiday + 1 volunteer day401(k) plan with company match up to 6% of salaryShare Appreciation RightsChoice of several healthcare plansFSA and HSA programsDental & vision careEmployer-paid basic term life/personal accident insuranceVoluntary disability, universal life/personal accident insuranceAccidental Death & Dismemberment (AD&D) InsuranceAdditional DetailsNothing 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.