Manager - Manufacturing Systems Integration Lead - IT

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

Work arrangement
No