Manager - Manufacturing Systems Integration Lead - IT

Job Description: Manufacturing Applications Integration Lead (Pharma Manufacturing)

Role: Manufacturing Applications Integration Lead
Team: Manufacturing IT / Digital Manufacturing
Experience: 1015 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 (L1L5): 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: Krber 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.