Automation Engineer

$97,600 - $146,400/Yr

Unclassified - Morris Plains, NJ

posted 4 months ago

Full-time - Mid Level
Morris Plains, NJ

About the position

In this role, you will be responsible for developing a comprehensive digital manufacturing strategy that incorporates elements of Industry 4.0, IIoT, artificial intelligence (AI), robotics, and cloud technologies. As the Automation Lead, you will oversee and manage the current automation systems in use across the facility, ensuring compliance with internal Good Manufacturing Practices (GMP), Computer System Validation (CSV), and external regulatory requirements. This position is critical to our mission of being the best manufacturer of Cell & Gene therapies, ensuring that our patients receive the treatments they need to live longer, healthier lives. You will develop strategies for data acquisition, systems integration, and smart manufacturing solutions to enable next-generation cell therapy operations. Your role will involve identifying areas where robotic solutions can enhance efficiency by automating manual processes. You will manage all aspects of the systems lifecycle and maintain the GxP validated state for all existing automation systems at the site. Additionally, you will be responsible for planning, developing, and executing automation projects from start-up to completion, collaborating with multiple departments to design, test, and maintain the functionality of automation systems. Providing and coordinating vendor training for new users of automation systems will also be part of your responsibilities. You will ensure compliance with Novartis Information Security Risk Management policies and provide technical support to operations and support personnel. Continuous updating of your technical knowledge and skills to reflect advancements in industry technology and processes will be essential to your success in this role.

Responsibilities

  • Develop strategies for data acquisition, systems integration, and smart manufacturing solutions (Industry 4.0 and Industrial IoT) to enable next-generation cell therapy operations.
  • Identify areas where the implementation of robotic solutions can enhance efficiency by automating manual processes.
  • Manage all aspects of the systems lifecycle and maintain the GxP validated state for all existing automation systems at the site.
  • Manage, plan, develop, and execute automation projects from start-up to completion.
  • Collaborate with multiple departments to design, test, and maintain the functionality of automation systems.
  • Provide and/or coordinate vendor training to new users of automation systems.
  • Ensure compliance with Novartis Information Security Risk Management policies.
  • Provide technical support to operations and support personnel.
  • Continually update technical knowledge and skills to reflect advancements in industry technology and processes.

Requirements

  • Bachelor's Degree in Engineering or related field is required.
  • 3+ years of relevant experience is required.
  • Extended interdisciplinary technical knowledge is required.
  • Experienced in a cGMP-regulated environment is required (pharmaceutical preferable).
  • Experience with automation systems (OSI PI, Continuum, Siemens, DeltaV, PLCs, etc.) is required.
  • Knowledge of IT infrastructure/networks related to automation systems.
  • Strong oral and written communication skills.
  • Ability to work independently with minimal direction.
  • Self-directed and able to manage competing priorities.
  • Must be able to work well with others in a team environment.
  • Strong computer skills.
  • Ability to focus on a variety of issues and drive to results.
  • Ability to interact with a variety of organizational levels and foster cross-functional and cross-cultural teamwork.
  • Working knowledge of Automation data technologies, standards, and protocols (e.g. OPC UA, MQTT, Modbus, UNS, ISA95, etc.).
  • Familiarity with industry standards 21 CFR Part 11, Validation, and GAMP.
  • Must be able to work in controlled environments requiring special gowning.
  • Good working GMP knowledge of pharmaceutical manufacturing facilities and major utilities.

Nice-to-haves

  • Experience with API (Application Programming Interface) development.
  • Knowledge of Kubernetes and back-end development.
  • Familiarity with risk management and root cause analysis (RCA).
  • Understanding of project commissioning and project engineering.

Benefits

  • 401(k) eligibility
  • Various paid time off benefits, including vacation, sick time, and parental leave
  • Sign-on bonus
  • Restricted stock units
  • Discretionary awards
  • Full range of medical and financial benefits
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