Senior Automation Engineer
Sr. Automation Engineer I
Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make: 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 in 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.
- 5+ years of related experience; or 3 years with a Master’s degree.
- Experience with a variety of PLCs, HMI hardware, and industrial sensors and applications.
- Controls design experience.
- General electrical design knowledge.
Preferred Qualifications:
- Minimum of 7 years of previous work experience in a related field.
- Working knowledge of cGMP, GAMP5, and regulatory requirements.
- Experience working with nasal spray products and devices or related drug-delivery devices.
- Industrial networking and server management.
- Technical writing experience includes SOPs, Maintenance PMs, user requirement specifications, and vendor requests for proposals.
- 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
Physical Requirements:
- Specific vision requirements include close vision, distance vision, color vision, and the ability to adjust and focus 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 safely perform assigned work.
- 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 and/or move up to 20 pounds.
# LI-Onsite
California residents should review our Notice for California Employees and Applicants before applying.
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
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Other details
- Job Family B - Engineering - Automation Engineering
- Job Function B - Engineering
- Pay Type Salary
- Lexington, KY, USA