Senior Automation Engineer II

Senior Automation Engineer II role at Kindeva Drug Delivery
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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 continually 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, 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

• Specific vision requirements include close vision, distance vision, color vision, and the ability to adjust and focus in order to read/understand/execute documentation as required by the position.
• Employees are required to follow all cGMP and safety procedures.
• The employee must wear all required safety equipment and perform assigned work in a safe manner.
• Employees must use proper lifting techniques and be conscious of hazards around them.
• Must follow all GMP and safety procedures within the department.
• The employee must occasionally lift…