Senior Automation Engineer II

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.

• 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.

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

• 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.

• 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.

• 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.

• 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.

• 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