Job Posting: Automation Engineer

      Indianapolis, IN


      Position Overview


      As an Automation Specialist/Engineer, you will serve as the administrator of our facilities automation systems and computerized production systems to ensure reliable and compliant operation. You will be expected to apply understanding of both equipment and pharmaceutical manufacturing processes, including operational efficiencies, process design, specifications, vendor management, qualification, safety and asset lifecycle management. Some experience with drug product manufacturing facilities and/or equipment is expected.



      Major Position Activities & Responsibilities


      • Serve as the technical expert and administrator for computerized systems such as Allen Bradley, Honeywell and Wonderware. Responsibilities include user access management across all systems to support facilities, manufacturing and packaging.
      • Design and perform routine maintenance tasks on computerized systems to ensure reliable operation and proper maintenance of backups.
      • Manage site SOPs and practices related to computerized systems to ensure CFR Part 11 compliance with emphasis on data integrity.
      • Provide daily support and oversight of site automation and lead periodic reviews of system performance to identify problem areas and drive continuous improvement.
      • Provide end-user training on the operator controls for these systems.
      • Support service work and system upgrades—including system administration tasks, coordination of vendor activities and qualification work.
      • Provide ongoing support to maintenance staff to solve complex problems, understand failure modes, and prepare technical solutions on computerized systems.
      • Serve as project lead and/or technical subject matter expert on site automation and computerized system projects.



      Background Qualifications


      • Bachelor’s in Engineering (Computer or Electrical preferred), or equivalence of certifications and experience.
      • Five or more years of experience in a manufacturing environment (pharmaceutical manufacturing is a plus)
      • Knowledge of CFR Part 11 (EudraLex Volume 4 Annex 11 and ISPE GAMP Guidelines a plus)
      • Building Automation Systems programming, troubleshooting and administration
      • Knowledge of Computerized Systems qualification/validation
      • Knowledge of Supervisory Control and Data Acquisition systems (SCADA) preferred
      • Must have good written and verbal skills
      • Requires manual dexterity, physical agility and the ability to lift 60 lbs.


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