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Automation Engineer

EPM Inc.
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 This job is to provide support to one of our clients that uses DeltaV control system in it’s cell therapy manufacturing processes. The ideal candidate will be responsible for designing, developing, and maintaining automation solutions within a DeltaV distributed control system (DCS) to optimize processing workflows. This role requires expertise in process automation, control strategies, and CGMP-compliant manufacturing environments. The Automation Engineer will collaborate with cross-functional teams to enhance operational efficiency, ensure data integrity, and maintain regulatory compliance.

Duties & Responsibilities

  • Develop, configure, and maintain DeltaV control strategies for cell therapy manufacturing processes, ensuring efficient automation of bioprocess workflows.
  • Implement and optimize batch automation solutions to support upstream and downstream processing, including media preparation, bioreactors, and purification systems.
  • Troubleshoot automation and control system issues, ensuring minimal downtime and process deviations.
  • Develop and maintain automation documentation, including functional specifications, validation protocols, and change control records in compliance with CGMP and regulatory guidelines.
  • Collaborate with process engineers, manufacturing teams, and quality assurance personnel to integrate automation solutions that enhance operational efficiency and product consistency.
  • Ensure compliance with 21 CFR Part 11 and data integrity requirements in automated process controls and electronic records management.
  • Participate in system validation activities, including Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and qualification protocols (IQ/OQ/PQ).
  • Manage automation change controls, implementing system updates while ensuring compliance with Good Automated Manufacturing Practice (GAMP) guidelines.
  • Monitor and maintain automation networks, interfaces, and control system security to ensure system reliability and data integrity.

Requirements & Qualifications

  • Bachelor’s degree in Engineering (Electrical, Chemical, or related field) or equivalent experience.
  • Experience with DeltaV Distributed Control System (DCS) is required; additional experience with other automation platforms is a plus.
  • Strong understanding of CGMP, FDA regulations, and 21 CFR Part 11 compliance in a biopharmaceutical or cell therapy manufacturing environment.
  • Proficiency in batch automation, process control strategies, and data historian tools.
  • Experience with scripting and automation languages (e.g., DeltaV Batch, S88, or S95 standards).
  • Familiarity with Biopharmaceutical processes, including upstream and downstream unit operations.
  • Strong troubleshooting skills with the ability to analyze and resolve automation-related deviations.
  • Excellent documentation skills and experience with validation in a regulated environment.
  • Ability to work in a fast-paced, team-oriented environment with cross-functional collaboration.