CSV & Change Control Specialist
- Manatí, PR
- Permanente
- Tiempo completo
Location: Manatí, PR
Duration: 6‑month initial term (renewable up to 3 years)Position OverviewWeilGroup is seeking two seasoned CSV & Change Control Specialists to support the Business Insights & Technology (BI&T) department at our Manatí site. You will own the end‑to‑end life cycle of electronic change controls and computerized system validation (CSV) projects, ensuring compliance with BMS standards, cGMP, 21 CFR Part 11, and all applicable regulations.Key ResponsibilitiesChange Control ManagementInitiate & Drive electronic change controls (e‑CC) from creation through closure—assign impact assessors, coordinate endorsements, and ensure system release for use.Collaborate with cross‑functional stakeholders (Quality, IT, Engineering) to review and update all related documentation.Communicate status, roadblocks, and requirements to BI&T leadership on a regular cadence.Computerized System Validation (CSV)Plan & Execute risk assessments (CSV & site) and develop, approve, and execute CSV deliverables:Validation Plans & Summary ReportsURS, Design/Functional Specifications, Configuration SpecificationsTraceability Matrices (initial and final)Factory/Site Acceptance Tests (FAT/SAT) and Installation/Operational Qualification (IQ/OQ) protocols & reportsMaintain all CSV artifacts in the BMS Document Management System; drive review and approval workflows.Documentation & TrainingDevelop/Revise SOPs for administration, security, backup, disaster recovery, and inventory control.Coordinate training sessions and capture completion records, forms, and follow‑up actions.Cybersecurity & Data IntegritySupport cybersecurity assessments and data‑integrity/data‑mapping exercises.Implement mitigation measures and ensure alignment with corporate IT security policies.Deliverables & MilestonesCompleted e‑CC records (initiation through closure)Approved CSV risk assessments and validation plansExecuted FAT/SAT, IQ/OQ/PQ protocols with supporting reportsUpdated URS, specifications, traceability matrices, and SOPsDashboards or summary reports tracking project progress and compliance statusTraining completion documentation and audit readiness evidenceMinimum QualificationsBachelor’s degree in Engineering, Computer Science, or related—or Master’s plus 1 year CSV/Change‑Control experience≥ 5 years of CSV and Change Control Management in a Pharmaceutical/Biotech environmentHands‑on experience developing and executing CSV deliverables (risk assessments, FAT/SAT, IQ/OQ/PQ)Proficient with Microsoft Office (Word, Excel, Project), CMMS, and Document Management SystemsFamiliarity with PI System, ColdStream, and TempTale preferredIn‑depth knowledge of cGMP, 21 CFR Part 11, GAMP 5, and FDA/local regulationsBilingual English/Spanish (written and oral)Core CompetenciesStrong project planning, organization, and multi‑taskingExcellent written and verbal communicationCollaborative mindset with ability to influence across levelsCustomer‑service orientation and proactive problem solvingSound judgment and commitment to quality and compliance