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Senior Pharmaceutical Automation Engineer

Visium Resources, Inc.

Clayton, NC

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JOB DETAILS
SKILLS
Acceptance Testing, Allen-Bradley, Analysis Skills, Automation, Automation Engineering, Automation Systems, Biotech and Pharmaceutical, Candidate Qualification, Change Control, Change Management, Code of Federal Regulations, Commissioning, Communication Skills, Computer Engineering, Consulting, Continuous Improvement, ControlLogix, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Quality, Data Recovery, Disaster Recovery, Documentation, Drug Manufacturing, Electrical Engineering, Engineering, Ethernet, FDA (Food and Drug Administration), Human Machine Interface (HMI), ISA Standards, Identify Issues, Industrial Development, Internet Security, Manufacturing, Manufacturing Automation, Manufacturing Equipment, Manufacturing Execution Systems (MES), Manufacturing Operations, Manufacturing Systems, Microsoft SQL Server, Microsoft Windows Server, Microsoft Windows System Administration, Network Configuration Management, On Site Support, Pallet Jack, Process Improvement, Production Support, Production Systems, Programmable Logic Controller (PLC), Quality Assurance, Quality Metrics, Reliability Engineering, Requirements Management, Root Cause Analysis, Standard Operating Procedures (SOP), Startup, Supervisory Control and Data Acquisition (SCADA), System Integration (SI), System Lifecycle, Systems Administration/Management, Team Player, Technical Support, Technical Writing, Testing, Virtualization
LOCATION
Clayton, NC
POSTED
Today

Introduction
Visium Resources has been asked to identify qualified candidates for this Senior Pharmaceutical Automation Engineer position. This position is a 12 month contract with anticipated renewals at a large Pharmaceutical company in Clayton, NC. This position is 5 days per week onsite.


Summary

We are seeking an experienced Senior Pharmaceutical Automation Engineer to support the implementation, commissioning, qualification, startup, and operational readiness of automated manufacturing systems for a major Fill Finish Expansion (FFEx) project within a state-of-the-art pharmaceutical manufacturing facility.

This role will provide technical automation support across multiple production and packaging systems, ensuring automation platforms are installed, tested, validated, and transitioned into reliable manufacturing operations while meeting FDA, cGMP, GAMP 5, and corporate quality standards. The ideal candidate possesses strong PLC, SCADA, MES, and pharmaceutical manufacturing automation experience with demonstrated success supporting highly automated production environments.


Primary Responsibilities

  • Provide automation engineering support for pharmaceutical manufacturing and packaging equipment throughout installation, commissioning, qualification, startup, and production support.
  • Troubleshoot and resolve automation-related issues impacting manufacturing operations.
  • Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
  • Review, troubleshoot, and modify PLC, HMI, SCADA, MES, and industrial network configurations as required.
  • Coordinate automation activities with engineering, validation, manufacturing, quality assurance, vendors, and system integrators.
  • Support change controls, deviations, CAPAs, and root cause investigations related to automation systems.
  • Participate in startup planning and execution while minimizing production downtime.
  • Develop and maintain automation documentation including:
    • Functional Specifications
    • Design Specifications
    • Software Change Documentation
    • Test Protocols
    • SOPs
    • System Configuration Documentation
  • Assist in cybersecurity, backup, disaster recovery, and system lifecycle management.
  • Ensure automation systems comply with FDA 21 CFR Part 11, cGMP, GAMP 5, and data integrity requirements.
  • Support long-term reliability improvements and continuous process optimization.

Manufacturing Equipment Supported

The Automation Engineer will support automation systems associated with highly automated pharmaceutical manufacturing and packaging equipment including:

Assembly Operations

FlexTouch (FxT) Assembly Lines

  • Mikron Assembly FlexCells
  • Mikron Handling Units
    • HUGP - Good Pen
    • HUMM - Motor Module
    • HUSA - Sub Assembly
  • Automated Palletizer

SDD Assembly Line

  • Cell 10 & 20 - Load SU/FA & Laser Mark
  • Cell 30 & 35 - Load Syringe
  • Cell 38 & 40 - Device Assembly
  • Cell 50 - Load RA

Packaging Operations

Support multi-vendor automated packaging equipment including:
  • Pester Depalletizer
  • Bausch + Stroebel Labeler
  • Fargo (Koerber) Transfer Unit
  • Dividella Cartoner
  • Robomat NeedlePak
  • Uhlmann Unit Serialization Platform (USP)
  • Uhlmann Track & Trace
  • Pester End-of-Line Palletizer

Automation Systems

Candidates should have experience with several of the following technologies:

PLC Platforms

  • Schneider Electric
  • B&R Automation
  • Allen-Bradley ControlLogix
  • Siemens PLCs

SCADA & HMI

  • FactoryTalk View
  • FactoryTalk Services
  • SCADA troubleshooting
  • Industrial HMI development

Manufacturing Systems

  • PAS-X Manufacturing Execution System (MES)
  • Historian systems
  • SQL Server
  • AVEVA PI System

Vision Systems

  • Cognex
  • Keyence
  • Vision Automation

Serialization

  • Uhlmann Track & Trace
  • Pharmaceutical serialization systems

Infrastructure

  • ThinManager
  • Octoplant
  • Industrial Ethernet networks
  • Virtualized automation environments
  • Windows Server administration (automation-related)


Required Qualifications

  • Bachelor's degree in Engineering, Automation Engineering, Electrical Engineering, Computer Engineering, or related technical discipline.
  • 5+ years of pharmaceutical or biotechnology automation engineering experience.
  • Experience supporting FDA-regulated manufacturing facilities.
  • Strong PLC troubleshooting experience with one or more major PLC platforms.
  • Experience supporting SCADA systems in pharmaceutical manufacturing.
  • Working knowledge of MES integration.
  • Experience supporting commissioning and qualification activities.
  • Understanding of ISA-88 and ISA-95 principles.
  • Familiarity with 21 CFR Part 11 and electronic records compliance.
  • Excellent troubleshooting and root cause analysis skills.
  • Strong communication and cross-functional collaboration abilities.

Preferred Qualifications

  • 8+ years of pharmaceutical automation engineering experience.
  • Experience supporting Fill Finish manufacturing facilities.
  • Experience with device assembly or high-speed packaging equipment.
  • Previous Novo Nordisk project experience.
  • Experience with PAS-X MES.
  • Experience with FactoryTalk SCADA architecture.
  • Knowledge of serialization systems.
  • Experience with AVEVA PI Historian.
  • Familiarity with ThinManager and Octoplant.
  • Experience supporting validated manufacturing environments.

Knowledge & Skills

  • PLC programming and troubleshooting
  • Industrial automation architecture
  • SCADA systems
  • MES integration
  • Industrial networking
  • Validation support
  • Commissioning and startup
  • Equipment integration
  • Root cause analysis
  • Change management
  • Vendor coordination
  • Continuous improvement
  • Pharmaceutical manufacturing operations
  • Data integrity and compliance
  • Technical documentation

Work Environment

  • On-site support within an active pharmaceutical manufacturing facility.
  • Frequent interaction with manufacturing, engineering, validation, quality, and equipment vendors.
  • Ability to support commissioning, startup, off-shift troubleshooting, and occasional weekend activities during project milestones.
  • May require gowning and work within classified manufacturing areas.

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Visium Resources is an award-winning employment firm with a mission to match talented individuals with highly successful organizations. At Visium, our company"s success is based on your success. When you work with us, you are never 'just a number'. You are our most important asset. Here, you will know us by name through our regular visits to client sites and even occasional luncheons. We will always be there when you need assistance and will always go the extra mile to ensure that you are as successful as possible. Whether you're looking for contract, contract-to-hire or permanent opportunities, we firmly believe there is no employment agency that will work harder for you than Visium.

Visium Resources is an equal opportunity employer and values diversity. All employment is decided based on qualifications, merit and business need.

About the Company

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Visium Resources, Inc.

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