Senior Automation Engineer II

Onsite Requirement

100% onsite

Location

Lexington, KY 91324

Position Id

2541

Recruiter Contact

KELLY

Job Description

As an Automation Engineer, you will play a vital role in designing, implementing, and maintaining automated systems to support pharmaceutical manufacturing in a cGMP environment. Your expertise will drive efficiency, improve equipment performance, and enhance product reliability. This role combines hands-on technical leadership with cross-functional collaboration to ensure automation systems meet operational needs and regulatory standards. Your work will support both innovation and day-to-day performance, ensuring continued compliance, safety, and productivity in a fast-paced, high-impact setting.

Responsibilities:

System Design and Development

  • Design, develop, and implement automated systems, including software, hardware, and processes.
  • Analyze existing systems, identify areas for automation, and create solutions that meet specific needs.
  • Configure and/or manage site-level automation systems (e.g., serialization, data historian, reporting, industrial networking).
  • Lead the design and procurement of new process and utility equipment and lead installation, start-up, commissioning or qualification activities, including authoring and/or reviewing IQ/OQ/PQ protocols, test execution, and authoring summary reports.
  • Support the development of site automation standardization and/or technology master plans.

Programming and Scripting

  • Write scripts and code to automate tasks, processes, and workflows using various programming languages.

Testing and Optimization

  • Test and optimize automated systems to ensure they function correctly and efficiently.
  • Identify and resolve issues and continuously improve system performance.
  • Implement improvements to existing equipment used to manufacture and package multiple types of nasal spray drug products.

Troubleshooting and Maintenance

  • Troubleshoot and resolve issues with automated systems, ensuring they operate smoothly.
  • Diagnose problems, implement fixes, and perform maintenance tasks.
  • Support maintenance activities, including review and approval of preventative maintenance tasks, calibration tolerances and intervals, drawing updates, execution of automation-related PMs (e.g., backup/restore), and support of out-of-tolerance investigations related to instrument calibrations.

Collaboration and Communication

  • Collaborate with other engineers, technicians, and stakeholders to develop and implement automation solutions.
  • Effectively communicate technical information and ensure project success.
  • Provide support to Manufacturing, Quality, Maintenance, and Validation for deviation investigations, change controls, and CAPAs through participation on cross-functional teams.
  • Participate in plant engineering, maintenance, and calibration activities as needed.
  • Other duties as assigned.

Qualifications:

Basic Qualifications:

  • BS in engineering/related degree or equivalent experience.
  • 8+ years of related experience; or 6 years with a master’s degree, or 3 years with a PhD.
  • Experience with a variety of PLCs, HMI hardware, and industrial sensors and applications.
  • Controls design experience.
  • General electrical design knowledge.
  • Working knowledge of cGMP, GAMP5, and regulatory requirements.
  • Technical writing experience such as: SOPs, Maintenance PMs, user requirement specs, vendor requests for proposal.

Preferred Qualifications:

  • Minimum of 8 years of previous work experience in a related field.
  • Experience working with nasal spray products and devices or related drug-delivery devices.
  • Industrial networking and server management.
  • Experience with site-level automation systems such as:
    • Serialization: Antares, Tracelink
    • Data historian: Aveva OSI PI
    • Reporting systems: OSI PI, MS Report Builder, SQL Development
    • Kepware, Matrikon, AB Factory Talk
    • Automated Visual Inspection
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