Lead Technical Architecture & Delivery
Design end-to-end MES architectures for PharmaSuite® and ProductionCentre®, integrating enterprise (ERP, LIMS, PLM), historians, and control systems.
Define hybrid/on-prem/cloud deployment models; author Solution Architecture Documents, Integration Designs, and Infrastructure-as-Code approaches.
Implement and configure FactoryTalk PharmaSuite® master batch records (MBRs), workflows, and equipment models; author/parameterize recipes and templates aligned to ISA‑88 and ISA‑95.
Configure FactoryTalk ProductionCentre® for discrete manufacturing (process steps, routing, non‑conformance, eDHR/eBR, SPC, genealogy, serialization).
Integration
Integrate MES with ERP (e.g., SAP/Oracle), LIMS, QMS, PLC/DCS/SCADA, historians (FactoryTalk Historian/PI), and lab/packaging systems using standard connectors and middleware.
Map data models and events across ISA‑95 layers; design robust exception handling and transactional integrity.
Modern Platform Enablement
Containerize and orchestrate application services using Docker and Kubernetes (AKS), leverage Helm for release management, and implement GitOps/CI-CD (Azure DevOps or GitHub Actions).
Engineers secure connectivity using Azure Private Link, VNET peering, APIM, and Key Vault for secrets.
Integration & Data Engineering
Implement reliable integrations (REST/GraphQL APIs, OPC UA, MQTT/AMQP, file-based) between MES and ERP (e.g., SAP/Oracle), LIMS, QMS, and historians.
Build data pipelines (batch/stream) with Azure Data Factory, Event Hubs, IoT Hub, and land curated data into Azure Data Lake for analytics.
Technical Validation & Delivery Excellence
Lead Computer System Validation (CSV) activities: author/review test strategies, IQ/OQ/PQ, traceability matrices, and SOPs in validated environments.
Drive backlog delivery with Agile tooling (JIRA, Azure DevOps), oversee code quality, and mentor developers on MES patterns and best practices.
Migration & Modernization
Build strategies and tooling to migrate from legacy MES/paper batch records to PharmaSuite®; orchestrate incremental transformations and cutovers with minimal production risk.
Stakeholder Engagement
Conduct technical workshops, demo POCs, and support presales by shaping solution approaches, estimates, and risk mitigations.
Coach peers and clients on technical practices, modifiability tactics, and reliable operations in regulated environments.
Platform, Cloud & DevOps
Support deployments on Azure (VMs, AKS, storage, networking, Key Vault), containerize services where applicable, and manage Kubernetes operations (helm, ingress, scaling, resilience).
Implement CI/CD pipelines (e.g., Azure DevOps/GitHub Actions), environment promotion, and configuration-as-code.
Support & Continuous Improvement
Provide hyper‑care, 2nd‑line support, root‑cause analysis, and performance tuning.
Coach client users, create SOPs/work instructions, and promote best practices for recipe governance and lifecycle management.

Requirements

Bachelor's Degree in a relevant field
Legal authorization to work in the U.S. We will not sponsor individuals for employment visas, now or in the future, for this job opening.
8+ years of experience in software engineering, systems design, or MES delivery.
8 + years of experience in MES configuration, integration or validation. (PharmaSuite®/ProductionCentre® or adjacent OT/IT solutions).
Familiarity with Axure, AKS/Kubernetes, Docker, and CI/CD practices for enterprise deployments.
Industry experience in Life Sciences, Pharmaceuticals, Bio-Tech, Medical Device or a regulated discrete manufacturing environment.
Comprehensive understanding of CSV/SDLC deliverables and audit readiness.

Benefits

Health Insurance including Medical, Dental and Vision
401k
Paid Time off
Parental and Caregiver Leave
Flexible Work Schedule where you will work with your manager to enjoy a work schedule that can be flexible with your personal life.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

MES architectureintegration designInfrastructure-as-CodeFactoryTalk PharmaSuiteFactoryTalk ProductionCentreREST APIsGraphQL APIsdata pipelinesComputer System ValidationAgile methodologies

Soft Skills

leadershipstakeholder engagementcoachingmentoringcommunicationproblem-solvingcollaborationtechnical workshopsrisk mitigationperformance tuning