Manager - Manufacturing Systems Integration Lead - IT

<p class="MsoNormal"><b>Job Description: Plant Applications Integration Lead (Pharma Manufacturing)</b></p><p><b></b></p><b></b><p class="MsoNormal"><b>Role:</b> Plant Applications Integration Lead<br /> <b>Team:</b> Manufacturing IT / Digital Manufacturing<br /> <b>Experience:</b> 10–15 years total, with at least 5 years integrating plant applications in pharma or regulated manufacturing, and at least 3 years in a lead role<br /> <b>Domain:</b> Pharma / Biotech / Life Sciences Manufacturing (GxP-regulated)<br /> <b>Employment Type:</b> Full-time</p><p></p><p class="MsoNormal"><b>Role Summary</b></p><p><b></b></p><b></b><p class="MsoNormal">We are looking for a Plant Applications Integration Lead to own the integration landscape connecting manufacturing plant applications with each other, with shop-floor automation, and with enterprise systems. Plant applications include MES/eBR, LIMS, historian, QMS, CMMS, WMS, serialization, electronic logbooks, environmental monitoring, and document management systems.</p><p></p><p class="MsoNormal">You will make sure data and transactions flow reliably and compliantly across the end-to-end manufacturing process, from process order creation to material dispensing, batch execution, testing, and batch release. The role combines solid manufacturing process understanding, hands-on integration expertise, and leadership of integration teams and system integrators across multiple plants.</p><p></p><p class="MsoNormal"><b>Key Responsibilities</b></p><p><b></b></p><b></b><p class="MsoNormal"><b>1. Plant Application Integration Ownership</b></p><p><b></b></p><b></b><ul style="margin-top:0cm;" type="disc"> <li class="MsoNormal">Own the integration strategy, roadmap, and landscape for all plant applications across sites.<p></p></li> <li class="MsoNormal">Maintain a complete <b>integration inventory</b>: interfaces, data flows, owners, protocols, GxP impact, criticality, and support model.<p></p></li> <li class="MsoNormal">Define integration standards, patterns, naming conventions, and reusable templates for consistent multi-site rollouts.<p></p></li> <li class="MsoNormal">Act as design authority for all plant application interfaces, reviewing and approving designs from project teams and vendors.<p></p></li> </ul><p class="MsoNormal"><b>2. End-to-End Manufacturing Process Integration</b></p><p><b></b></p><b></b><ul style="margin-top:0cm;" type="disc"> <li class="MsoNormal">Design and deliver integrations supporting core manufacturing business flows, including: <p></p><ul style="margin-top:0cm;" type="circle"> <li class="MsoNormal"><b>ERP to MES:</b> process orders, recipes/master data, material master, BOM, and routing download<p></p></li> <li class="MsoNormal"><b>MES to ERP:</b> material consumption, goods movements, yield, order confirmations, and batch status<p></p></li> <li class="MsoNormal"><b>WMS/ERP to MES:</b> dispensing, material staging, and inventory status<p></p></li> <li class="MsoNormal"><b>MES to automation (DCS/PLC/SCADA):</b> recipe parameters, equipment status, and process data<p></p></li> <li class="MsoNormal"><b>Historian to MES/eBR:</b> critical process parameters and batch context<p></p></li> <li class="MsoNormal"><b>LIMS to ERP/MES:</b> sample creation, test results, usage decisions, and batch disposition<p></p></li> <li class="MsoNormal"><b>QMS integration:</b> deviations, CAPA, and change control linked to batches and equipment<p></p></li> <li class="MsoNormal"><b>CMMS/EAM integration:</b> equipment status, calibration, maintenance, and logbook data<p></p></li> <li class="MsoNormal"><b>Serialization/track-and-trace (L1–L5):</b> line-level serialization, site server, and corporate/regulatory reporting<p></p></li> <li class="MsoNormal"><b>Environmental monitoring and BMS:</b> cleanroom, HVAC, and storage condition data<p></p></li> <li class="MsoNormal"><b>Document management systems:</b> master batch records, SOPs, and effective document versions<p></p></li> </ul></li> <li class="MsoNormal">Ensure integrations support batch record review, review by exception, and faster batch release.<p></p></li> </ul><p class="MsoNormal"><b>3. Integration Design and Technical Leadership</b></p><p><b></b></p><b></b><ul style="margin-top:0cm;" type="disc"> <li class="MsoNormal">Lead integration design using appropriate patterns: real-time, event-driven, batch, file-based, and API-based.<p></p></li> <li class="MsoNormal">Define interface specifications (ICDs), data mapping, transformation rules, error handling, retries, reconciliation, and alerting.<p></p></li> <li class="MsoNormal">Guide implementation on middleware and integration platforms such as SAP PI/PO, SAP Integration Suite, SAP PCo, MuleSoft, Boomi, Azure Integration Services, Kafka, or vendor-specific connectors.<p></p></li> <li class="MsoNormal">Apply industrial standards including <b>ISA-95, ISA-88, B2MML, OPC UA, and MQTT</b> where relevant.<p></p></li> <li class="MsoNormal">Work closely with the IT-OT Integration Architect, Historian Architect, MES and LIMS leads, and OT security to ensure designs are secure, scalable, and aligned with the Purdue model.<p></p></li> <li class="MsoNormal">Ensure master data consistency (materials, equipment, recipes, sites, units of measure) across integrated systems.<p></p></li> </ul><p class="MsoNormal"><b>4. Project Delivery and Implementation</b></p><p><b></b></p><b></b><ul style="margin-top:0cm;" type="disc"> <li class="MsoNormal">Lead the integration workstream for new plant application implementations, upgrades, migrations, and site rollouts.<p></p></li> <li class="MsoNormal">Plan integration scope, effort, timelines, dependencies, and resources with project managers and vendors.<p></p></li> <li class="MsoNormal">Coordinate system integration testing (SIT), end-to-end process testing, and support UAT with business users.<p></p></li> <li class="MsoNormal">Plan cutover, data migration, and go-live activities around production schedules and shutdowns.<p></p></li> <li class="MsoNormal">Provide hypercare after go-live and hand over to support teams with complete documentation.<p></p></li> </ul><p class="MsoNormal"><b>5. GxP Compliance, Validation and Data Integrity</b></p><p><b></b></p><b></b><ul style="margin-top:0cm;" type="disc"> <li class="MsoNormal">Ensure all integrations comply with <b>21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+</b> principles.<p></p></li> <li class="MsoNormal">Classify interfaces by GxP impact and apply risk-based validation (CSV/CSA).<p></p></li> <li class="MsoNormal">Author or review interface URS, functional and design specifications, risk assessments, test protocols (IQ/OQ/PQ), and traceability matrices.<p></p></li> <li class="MsoNormal">Design controls for data completeness and accuracy, including reconciliation, duplicate prevention, audit trails, failure alerts, and manual fallback procedures.<p></p></li> <li class="MsoNormal">Support change control, periodic reviews, and regulatory inspections (USFDA, EMA, MHRA, WHO-GMP) as the integration SME.<p></p></li> <li class="MsoNormal">Ensure multi-site integrations maintain clear site-level separation of data and responsibilities.<p></p></li> </ul><p class="MsoNormal"><b>6. Integration Operations and Support</b></p><p><b></b></p><b></b><ul style="margin-top:0cm;" type="disc"> <li class="MsoNormal">Establish integration monitoring, dashboards, and alerting for interface health, message failures, and backlogs.<p></p></li> <li class="MsoNormal">Act as the escalation point for integration incidents and lead root cause analysis.<p></p></li> <li class="MsoNormal">Define support processes, SLAs, runbooks, and error-handling procedures with IT operations and site teams.<p></p></li> <li class="MsoNormal">Drive continuous improvement to reduce interface failures and manual workarounds.<p></p></li> </ul><p class="MsoNormal"><b>7. Stakeholder and Team Leadership</b></p><p><b></b></p><b></b><ul style="margin-top:0cm;" type="disc"> <li class="MsoNormal">Partner with Manufacturing, QA, QC, Engineering, Warehouse, Supply Chain, and IT stakeholders to understand requirements and priorities.<p></p></li> <li class="MsoNormal">Lead and mentor integration developers, analysts, and consultants.<p></p></li> <li class="MsoNormal">Manage system integrators and application vendors on scope, quality, and delivery timelines.<p></p></li> <li class="MsoNormal">Report integration status, risks, and performance to IT and business leadership.<p></p></li> </ul><p class="MsoNormal"><b>Required Skills and Experience</b></p><p><b></b></p><b></b><ul style="margin-top:0cm;" type="disc"> <li class="MsoNormal">Strong understanding of <b>pharma manufacturing processes</b>: process orders, dispensing, batch execution, IPC, BMR/eBR, sampling and testing, batch review and release, deviations, and equipment management.<p></p></li> <li class="MsoNormal">Hands-on integration experience with plant applications such as: <p></p><ul style="margin-top:0cm;" type="circle"> <li class="MsoNormal"><b>MES:</b> Körber PAS-X, Emerson Syncade, Siemens Opcenter, Rockwell PharmaSuite, or similar<p></p></li> <li class="MsoNormal"><b>LIMS:</b> LabWare, LabVantage, STARLIMS, Waters Empower (CDS)<p></p></li> <li class="MsoNormal"><b>ERP:</b> SAP ECC/S/4HANA (PP-PI, QM, MM, WM/EWM, PM)<p></p></li> <li class="MsoNormal"><b>Historian:</b> AVEVA PI, AspenTech IP.21, Honeywell PHD, or similar<p></p></li> <li class="MsoNormal"><b>QMS/DMS:</b> TrackWise, Veeva Vault, MasterControl, Documentum<p></p></li> <li class="MsoNormal"><b>Serialization:</b> Systech, TraceLink, Optel, Antares, rfxcel<p></p></li> </ul></li> <li class="MsoNormal">Experience with integration platforms and middleware (SAP PI/PO/CPI, SAP PCo/MII, MuleSoft, Boomi, Azure Integration Services, Kafka).<p></p></li> <li class="MsoNormal">Strong knowledge of APIs (REST/SOAP), message queues, IDocs, file-based interfaces, and data mapping.<p></p></li> <li class="MsoNormal">Knowledge of ISA-95, ISA-88, B2MML, and OPC UA.<p></p></li> <li class="MsoNormal">Proven delivery of validated GxP integrations in regulated manufacturing.<p></p></li> <li class="MsoNormal">Working knowledge of SQL and scripting (Python, PowerShell, or similar) for troubleshooting and data reconciliation.<p></p></li> </ul><p class="MsoNormal"><b>Preferred Qualifications</b></p><p><b></b></p><b></b><ul style="margin-top:0cm;" type="disc"> <li class="MsoNormal">Bachelor's or Master's degree in Engineering (Computer, Instrumentation, Chemical, Electronics), Pharmacy, or Information Technology.<p></p></li> <li class="MsoNormal">Certifications such as SAP Integration, MuleSoft, Azure Integration, PMP/PRINCE2, ITIL, or ISA-95/MESA.<p></p></li> <li class="MsoNormal">Experience with multi-site or global plant application rollouts and Pharma 4.0 initiatives.<p></p></li> <li class="MsoNormal">Exposure to cloud integration, data platforms, and AI/analytics use cases built on manufacturing data.<p></p></li> </ul><p> </p><p class="MsoNormal"></p><p> </p>