Jobs · Analyst

IT/OT Project Lead – PI Historian & Dream Report Implementation

QvalFocus Inc. · United States · 1 wk ago
RemoteRemoteAnalystContract
Position SummaryWe are seeking an experienced IT/OT Project Manager to lead a PI Historian and Dream Report implementation within a regulated pharmaceutical manufacturing environment.The Project Manager will be responsible for overall project planning, execution, coordination, schedule management, risk and issue management, vendor coordination, testing, commissioning, validation activities, and project closeout.The ideal candidate does not need to be the deepest PI Historian technical SME but should have strong experience managing automation, IT/OT, digital manufacturing, CSV, or GMP technology projects. Key ResponsibilitiesLead overall project planning, coordination, execution, reporting, and delivery.Develop and maintain project schedules, milestones, resource plans, and deliverable trackers.Coordinate activities across automation, PI Historian, CSV, IT, OT, engineering, quality, facilities, OEMs, and external vendors.Manage project risks, issues, dependencies, decisions, and action items.Track project scope and support formal change-control processes.Coordinate equipment integration, data connectivity, testing, commissioning, and qualification activities.Facilitate technical and project meetings with internal stakeholders, vendors, and equipment suppliers.Ensure PI Historian, Dream Report, automation, and CSV activities remain aligned with the overall project schedule.Coordinate FAT/SAT, commissioning, IQ/OQ/PQ, validation, and production-readiness activities as applicable.Monitor project deliverables including specifications, drawings, test scripts, validation documents, configuration records, and turnover packages.Provide regular project status updates and escalate schedule, technical, or compliance risks.Support project closeout, punch-list completion, turnover, and final documentation. Required Qualifications8+ years of project management experience, preferably within pharmaceutical, biotech, or other regulated manufacturing environments.Experience managing IT/OT, automation, manufacturing systems, digital manufacturing, historian, MES, SCADA, BMS, EMS, or CSV projects.Working understanding of GMP project execution and computerized system validation.Experience coordinating engineering, automation, quality, IT, validation, and vendor teams.Strong schedule, risk, issue, change-control, and resource-management experience.Familiarity with commissioning, qualification, and validation lifecycle activities.Strong communication and stakeholder-management skills. Preferred ExperiencePI Historian / AVEVA PI implementation projects.Dream Report or similar industrial reporting platforms.Pharmaceutical manufacturing, sterile manufacturing, biologics, or radiology and therapy environments.Equipment connectivity, OT networks, middleware, PLC/SCADA, EMS/BMS, or data historian integrations.PMP or similar project-management certification.

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