Advanced Manufacturing Tech Solutions (AMTSOL) - www.amtsol.comA Leader in Life science Manufacturing Technology solutions, we are looking for top talent to be part of the dynamic team and drive the growth of the business.Role OverviewWe are looking for a Mid-Level CSV Engineer to support validation activities for GMP-regulated computerized systems across manufacturing, packaging, and laboratory environments. The role focuses on hands‑on execution of CSV lifecycle deliverables, working closely with Quality, Engineering, IT, and project teams to ensure compliance and timely delivery.Key ResponsibilitiesExecute CSV lifecycle activities for GMP computerized systems, including MES, DCS, SCADA, and automated equipmentPrepare, review, and support approval of CSV documentation (Validation Plans, URS, Risk Assessments, IQ/OQ/PQ, Reports)Support risk‑based validation approaches for new and existing systemsEnsure CSV activities comply with cGMP, GAMP 5, Annex 11, and 21 CFR Part 11Support project teams to align validation activities with project timelinesParticipate in validation risk assessments to define appropriate testing scopeReview system specifications, design documents, installation records, and qualification documentationSupport CSV activities across manufacturing, packaging, and laboratory systemsGenerate, track, and support closure of validation deviations and discrepanciesSupport investigations and assess data integrity risks during validation and routine operationsPerform periodic reviews of computerized systems and assist in identifying compliance gapsSupport the development and maintenance of CSV / Qualification SOPsAssist in regulatory inspections and internal auditsCollaborate with local and global CSV teams to ensure consistent executionEscalate potential quality or compliance issues to senior CSV or Quality leadsFollow EHS and site safety procedures during commissioning and validation activitiesQualifications & ExperienceBachelors degree in Engineering, Life Sciences, Computer Science, or related discipline4–7 years of experience in Computer System Validation within a regulated pharma / biopharma environmentSolid understanding of CSV regulations and quality expectationsHands‑on experience validating GAMP Category 3, 4, and 5 systemsExperience executing validation protocols and managing validation documentationWorking knowledge of Annex 11, 21 CFR Part 11, and GAMP guidelinesExperience supporting investigations, root cause analysis, and CAPAsStrong documentation, and cross‑functional collaboration skills
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