Senior Pharmaceutical Automation Engineer
Job Location:
Clayton, OH - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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
- 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.
- Mikron Assembly FlexCells
- Mikron Handling Units
- HUGP - Good Pen
- HUMM - Motor Module
- HUSA - Sub Assembly
- Automated Palletizer
- Cell 10 & 20 - Load SU/FA & Laser Mark
- Cell 30 & 35 - Load Syringe
- Cell 38 & 40 - Device Assembly
- Cell 50 - Load RA
- 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
- Schneider Electric
- B&R Automation
- Allen-Bradley ControlLogix
- Siemens PLCs
- FactoryTalk View
- FactoryTalk Services
- SCADA troubleshooting
- Industrial HMI development
- PAS-X Manufacturing Execution System (MES)
- Historian systems
- SQL Server
- AVEVA PI System
- Cognex
- Keyence
- Vision Automation
- Uhlmann Track & Trace
- Pharmaceutical serialization systems
- ThinManager
- Octoplant
- Industrial Ethernet networks
- Virtualized automation environments
- Windows Server administration (automation-related)
- Bachelors 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.
- 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.
- 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
- 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.
Visium Resources is an award-winning employment firm with a mission to match talented individuals with highly successful organizations. At Visium our companys 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 youre 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.
Required Experience:
Senior IC
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