Role OverviewThe Automation CSV Engineer is responsible for supporting validation, compliance, testing, and technical documentation activities for GMP automation systems within a regulated manufacturing environment.
What You Will Do
The position is responsible for developing validation strategies, preparing and executing lifecycle documentation, assessing automation changes, and helping maintain systems in a controlled and validated state.
Why It Might Be a Fit
Successful candidates will have practical experience with platforms such as Emerson DeltaV, OSIsoft PI or AVEVA PI System, SCADA, PLC-based controls, batch systems, and associated interfaces.
Requirements
- Bachelor’s degree in Engineering, Computer Science, Information Systems, Biotechnology, Life Sciences, or a related technical discipline, or an equivalent combination of education and relevant experience.
- At least five years of experience in automation validation, computer system validation, commissioning and qualification, automation engineering, or computerized system quality within a regulated environment.
- Working experience with one or more industrial automation technologies, such as: Emerson DeltaV, AVEVA PI System or OSIsoft PI, SCADA platforms, PLC and HMI systems, batch control systems, manufacturing data collection or reporting applications.
- Experience creating and executing validation or qualification deliverables, including FAT, SAT, IQ, OQ, PQ, regression testing, or automation functional testing.
- Demonstrated ability to author clear, technically accurate validation documentation.
- Knowledge of GMP system lifecycle controls and applicable requirements or guidance, including: 21 CFR Part 11, EU GMP Annex 11, GAMP 5, data integrity principles, risk-based computerized system assurance practices.
- Experience working within formal quality systems, including change control, deviations, CAPAs, and risk management.
- Understanding of automation system architecture, interfaces, configuration management, and operational support.
- Ability to manage multiple deliverables and priorities while maintaining documentation quality and schedule awareness.
- Strong communication skills and the ability to work effectively with both technical and nontechnical stakeholders.
Benefits
- Discretionary annual bonus
- Comprehensive benefits to include Medical, Dental and Vision
- Short-term and long-term disability
- Company paid basic life insurance
- 401k company match
- Flexible work
- Generous paid time off
- Paid holiday
- Wellness and transportation benefits
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