Senior MES Technical Consultant

Role Overview

• 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.

Tech Stack

• Axure
• Azure
• Cloud
• Docker
• ERP
• GraphQL
• IoT
• Kubernetes
• Oracle
• SDLC
• Vault

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.