Senior CSV Validation Engineer

Senior 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 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 ResponsibilitiesLead 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 applicationsReview and approve qualification documentation on behalf of the validation functionEvaluate, audit, and guide software validation activities to ensure compliance with FDA, EU, ISO, Data Integrity guidances, and internal procedures and standardsAssess the impact of system-related events on the system's validated state and data reliability.Lead validation execution and ensure testing is appropriately documentedSupport 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 actionsDevelop, author and improve CSV procedures, templates, standards, and guidance. Monitor industry and regulatory trends and recommend improvements to company practicesSupport the execution and generation of formal risk assessmentsSupport and conduct periodic reviewsSupport the evaluation of data lifecycles and data flow from creation through processing, review, approval, reporting, retention, and archivalSupport risk-based Data Integrity Assessments and the audit trail review processIdentify data integrity risks and partner with system owners to implement remediation plansProvide 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 requirementsPromote a strong data integrity culture across GxP functionsSupport audits and regulatory inspections in representing CSV, as neededSpecial Job RequirementsAdaptability required as work schedule may change based on business needsCriminal background check requiredOther duties as assignedEducation / Certifications / LicensesA minimum of a bachelor's degree in Engineering, Computer Science or related disciplineOn-the-Job Experience7+ years of Computer System Validation experienceStrong 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 strategiesExperience with computerized system periodic reviewsExperience with audit trail and data integrity assessmentsSkills / AbilitiesThe ability to communicate effectively with employees of all experience levels from Genezen and other contract firmsThe ability to report on project activity in a clear and concise mannerThe ability to communicate and work effectively with fellow project team membersAbility to work well with diverse groups in a matrix-style, growing, safety focused organizationUnderstanding of cGMP regulationsStrong technical writing skillsStrong working knowledge in Microsoft Office (Word, Excel, Visio, etc.) and Adobe AcrobatStrong project management skills with the ability to manage multiple activities with challenging timelinesStrong working knowledge of 21 CFR Part 11, EU GMP Annex 11, ICH guidelines, GAMP 5 and data integrity guidelinesCompensation RangeThe anticipated annual salary range for the Sr. Validation CSV positions is $115,000-$140,000.Physical DemandsWhile performing the duties of this job, the employee is required to meet the following physical demands:Work EnvironmentRegularly sit for long periods of time.MovementFrequently required to stand; sit; walk; balance; stoop; kneel; crouch; 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.