Validation Engineer

OverviewWe are seeking an experienced CQV Engineer to support a GMP facility restart within a biologics manufacturing environment. This role will focus on commissioning, qualification, and validation activities across upstream and downstream processing systems, ensuring compliance with regulatory standards.This is an excellent opportunity to work on a high-impact project involving technology transfer, documentation, and compliance (including Annex 11) in a fast-paced, regulated setting.Key ResponsibilitiesLead and execute CQV activities for process equipment, utilities, and systems within a biologics facilitySupport GMP restart/remediation efforts, ensuring systems are inspection-readyDevelop and review validation lifecycle documentation (URS, DQ, IQ, OQ, PQ, protocols, and reports)Ensure compliance with GMP standards and EU Annex 11 requirementsCollaborate cross-functionally with QA, Manufacturing, Engineering, and MSAT teamsSupport technology transfer activities, including process and equipment handoverDrive and support risk assessments (e.g., FMEA) and deviation investigationsEnsure strong data integrity and documentation practicesParticipate in commissioning and qualification testing executionRequired Experience5–7 years’ experience in CQV / Validation within pharma / biotech / biologicsProven experience supporting GMP manufacturing environments, ideally with facility restart, remediation, or start-up projectsHands-on experience with upstream and/or downstream processing systemsStrong knowledge of validation lifecycle and documentation standardsExperience with Annex 11 / CSV (Computer System Validation)Key SkillsStrong technical writing and documentation skillsSolid understanding of GMP regulations and compliance frameworksExperience with technology transfer processesExcellent stakeholder engagement and cross-functional collaborationAbility to work in a fast-paced, project-driven environment