Decommissioning Engineer / CQV Specialist (ALM & Doc Control)
- Manatí, PR
- Autónomo
- Tiempo completo
Type: Contract – Capital Project Support
Department: Operations / Engineering / QualitySummaryWe are seeking a Decommissioning Engineer / CQV Specialist to support a Cease-of-Operations decommissioning project in a parenteral/lyophilization manufacturing area. The role will lead the retirement/decommissioning of ~22 equipment assets, author and execute decommissioning plans and tests, and ensure all documentation is created, reviewed, approved, and archived in the site’s Document Control system and ALM (Application Lifecycle Management) platform in accordance with cGMP and data-integrity requirements.Key ResponsibilitiesDecommissioning Strategy & PlanningAuthor the Decommissioning/Retirement Plan for a defined equipment list (≈22 assets).Define scope, impact, and acceptance criteria; align with Engineering, QA, Operations, and Validation.Prepare and obtain approvals for the Decommissioning Plan and the Decommissioning Plan Summary Report.Documentation & ApprovalsMonitor the offline review cycle; track comments, resolutions, and approvals.Upload / route records in the site Doc Control system (e.g., Veeva/Infinity/BMSDocs or equivalent) and ALM, ensuring metadata accuracy and audit-ready traceability.Maintain change logs, version control, and approval history; ensure timely turnover of all records.Test Authoring & ExecutionDevelop Decommissioning/Retirement Tests within ALM (protocols, forms, checklists).Coordinate & execute test activities (equipment isolation, data migration/backup, labeling, status changes).Serve as Execution Verifier in ALM; document objective evidence and record outcomes.Reporting & CloseoutCompile Decommissioning Summary Reports, including evidence, variances, and residual risk.Ensure proper asset status updates, tag removal/lockout documentation, and archival/retention actions.Support readiness for internal/external audits and provide status updates to project leadership.Required QualificationsBS in Engineering, Computer Science, or related discipline.3–5+ years in pharmaceutical/biotech or other cGMP regulated environments.Hands-on experience with equipment decommissioning/retirement, CQV, or CSV activities.Proficiency with ALM (test authoring/execution) and Document Control systems (e.g., Veeva/Infinity/Documentum/BMSDocs or similar).Strong knowledge of cGMP, data integrity, change control, and good documentation practices.Excellent technical writing, organization, and cross-functional communication skills; ability to manage multiple reviews/approvals on tight timelines.Bilingual Spanish/English.Preferred QualificationsPrior decommissioning experience in lyophilization / parenteral areas (utilities, lyo skids, WFI/Clean utilities, process support equipment).Familiarity with risk assessments, asset lists/BOMs, and equipment master data closeout.Experience with audit readiness and responding to quality observations.Success MetricsOn-time approval of Decommissioning Plans, Tests, and Summary Reports.100% compliant uploads/metadata in Doc Control & ALM; zero overdue items.Audit-ready documentation with complete traceability and evidence.