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Senior Automation Specialist

2 months ago

Durham, North Carolina, United States Novartis Group Companies Full time

Position Overview

The Senior Automation Specialist plays a crucial role in the automation design teams, focusing on the support and enhancement of specific systems within a gene therapy manufacturing environment. This position entails maintaining, diagnosing, and adjusting both GMP and non-GMP control systems, which encompass a comprehensive plant-wide DCS (DeltaV), BMS (Rockwell SCADA), and various third-party local control systems.

Key Responsibilities:

  • Assist in the upkeep, troubleshooting, and modification of GMP and non-GMP control systems.
  • Engage in the design, configuration, installation, and maintenance of automation software and related hardware, collaborating with other teams as necessary.
  • Draft scopes of work for small to medium-sized automation initiatives.
  • Establish project objectives aligned with user requirements and business strategies.
  • Participate in discussions with internal stakeholders regarding priorities, timelines, and transparent information sharing.
  • Develop and update equipment specifications in standard documentation, including User Requirements (URS), Functional Specification (FS), and Detail Design Specifications (DDS/HDS/SDS).
  • Maintain procedures to comply with GMP standards, CFR regulations, and internal company policies.
  • Provide support for 24/7 site operations, including rotating on-call duties.

Qualifications:

  • Bachelor's degree in Engineering, Computer Science, or a related technical field, or 6 years of equivalent work experience in lieu of a degree.
  • A minimum of 2 years of experience in pharmaceutical or biopharmaceutical GMP manufacturing operations, or 6 years of equivalent experience.
  • Proficiency in programming, troubleshooting, and initiating PLC and/or DCS systems, with a preference for DeltaV DCS and Rockwell PLC experience.
  • Ability to work effectively in a team environment, demonstrating excellent communication and organizational skills.
  • Experience in executing test protocols for automation system-level commissioning and qualification.
  • Familiarity with executing change controls within change management systems.
  • Working knowledge of field device signal wiring practices, panel design, instrumentation, and modern industrial communication protocols.
  • Understanding of FDA regulations, particularly 21 CFR part 11, and GMP systems.

Why Choose Novartis:

At Novartis, our mission is to reimagine medicine to enhance and prolong lives. We aspire to be the most valued and trusted medicines company globally, and our people are the driving force behind our daily efforts to achieve these goals. We offer a competitive compensation package that may include various elements such as a sign-on bonus, restricted stock units, and discretionary awards, along with a comprehensive range of medical, financial, and other benefits.

Diversity and Inclusion:

The Novartis Group of Companies is an Equal Opportunity Employer, committed to fostering a diverse environment. We do not discriminate in recruitment, hiring, training, promotion, or other employment practices based on race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility:

We are dedicated to providing reasonable accommodations to individuals with disabilities. If you require assistance during the application process or need accommodations to perform essential job functions, please reach out to us.