Automation Engineer II
5 days ago
Job Description Summary
The Automation Engineer II is responsible for participating on automation design teams and supporting specific systems for a Novartis gene therapy manufacturing facility. This includes responsibilities for helping to maintain, troubleshoot, and modify the GMP and non-GMP control systems. Systems include plant-wide DCS (DeltaV), BMS (Rockwell SCADA) and 3rd party local control systems.
Job Description
Responsibilities:
- Helps to maintain, troubleshoot, and modify the GMP and non-GMP control systems.
- Participates in the design, configuration, installation, and maintenance of automation software and associated hardware, including interacting with other teams as necessary.
- Prepares scopes of work for small to medium-sized automation projects.
- Develops project objectives working with user requirements and business plans.
- Participates in discussions with internal business partners on priorities, timelines, and transparent sharing of information.
- Develops/updates equipment specifications in standard documentation - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS).
- Maintains procedures to meet GMP requirements, CFR's and internal company policies.
- Supports 24x7 site-based operations, including rotating on-call responsibilities.
Requirements:
- B.S. degree in Engineering, Computer Science, or related technical field or 6 years of equivalent work experience in lieu of degree.
- 2 years' work experience in pharmaceutical or biopharmaceutical-based GMP manufacturing operations; or 6 years equivalent work experience.
- Experience programming, troubleshooting, and start-up of PLC and/or DCS systems and troubleshooting manufacturing equipment utilizing these systems. DeltaV DCS and Rockwell PLC experience preferred.
- Working in a team environment, with excellent communication and organizational skills.
- Experience in executing test protocols for automation system level commissioning and qualification.
- Experience executing change controls in change management systems.
- Working knowledge of field device signal wiring practices/panel design, instrumentation, and modern industrial communication protocols.
- Familiarity with FDA regulations, particularly 21 CFR part 11 and GMP systems.
Why Novartis:
Our purpose is to reimagine medicine to improve and extend people's lives, and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us.
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