Manager - Manufacturing Systems Integration Lead - IT

Job Description: Plant Applications Integration Lead
(Pharma Manufacturing)
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:

Experience
10 - 15 Years

Employment type
C-C8-Confirmed-HO Executive

Work arrangement
No