Validation Engineer

Validation EngineerLocation: Boston/Cambridge, MAIndustry: Cell & Gene Therapy / Life SciencesJob Description: We are seeking a Validation Engineer to support qualification, requalification, and validation activities within a GMP-regulated Cell and Gene Therapy facility. This role will focus on ensuring facilities, utilities, equipment, and systems meet applicable quality and regulatory requirements.Responsibilities:Develop, review, and execute validation and qualification protocols, plans, and reportsSupport requalifications, periodic assessments, and CQV projectsQualify facilities, utilities, laboratory equipment, and manufacturing systemsPerform risk and impact assessments as neededCollaborate with Engineering, QA, EHS, Project Management, and other cross-functional teamsCoordinate vendors supporting validation activitiesEnsure compliance with cGMP, SOPs, GAMP, ISO, CFR, and applicable standardsSupport continuous improvement and right-first-time documentation practicesRequirements:Bachelor's degree in Engineering or a related technical field3–8 years of Validation/CQV experience in a GMP environmentExperience writing and executing qualification protocolsKnowledge of GMP, CFR, ISO, GAMP, and related standardsStrong technical problem-solving and communication skillsAbility to work independently and adapt to changing prioritiesBenefits (employee contribution):Health insuranceHealth savings accountDental insuranceVision insuranceFlexible spending accountsLife insuranceRetirement plan