Job Summary
Serialization, systech and vision systems
Job Description About the role The Principal Serialization Automation Engineer plays a critical role within the Automation and Packaging Engineering Department, ensuring the optimal and cost-effective performance of Systech serialization systems, vision inspection systems, and other automation technologies across filling and packaging lines. This position requires close collaboration with Maintenance and Operations teams to provide timely, hands-on troubleshooting support for production issues-minimizing downtime and driving continuous improvement. The engineer will take ownership of recurring issues, lead root cause analysis (RCA), and implement corrective and preventive actions (CAPA) to enhance system reliability and performance. Overview of Activities · Independently lead the execution of process and production systems support, ensuring timely issue resolution and minimizing production downtime. Proactively identify and implement system improvements through data analysis, technical expertise, and industry best practices to enhance reliability and operational efficiency. · Manage the execution of Vision Inspection and Serialization systems for medium to large capital projects, serving as the engineering lead for packaging automation within cross-functional teams. · Evaluate existing equipment and control systems across manufacturing areas and determine necessary modifications to meet design and reliability standards. · Develop and review automation strategies for manufacturing processes, support equipment, and systems. This includes preparing design documentation, drawings, and procurement packages. · Serve as a technical approver for protocols and support documentation (e.g., engineering change requests, system change forms), ensuring compliance with validation requirements and project readiness. · Create or update technical specifications (Design, Functional, System) aligned with assigned project scopes. · Supervise contractors and junior engineering staff on project execution and daily activities. · Demonstrate a commitment to continuous improvement by expanding job knowledge, technical proficiency, and problem-solving capabilities within the biopharmaceutical industry. · Provide hands-on technical support for diagnostics and troubleshooting of automation systems during production. Collaborate closely with maintenance teams to ensure rapid resolution and drive continuous design enhancements. · Lead the design, implementation, and validation of changes to Systech serialization and vision systems/ Illuminate, ensuring compliance with change control procedures and minimizing operational disruptions. · Investigate automation-related events and implement corrective actions. Develop standard operating procedures (SOPs) and work instructions for packaging, filling, and processing systems. · Design and deliver targeted training programs on critical automation systems for maintenance and production personnel to enhance troubleshooting capabilities and operational knowledge. What you bring to the role · A bachelor’s degree in engineering, preferably in Electrical, Mechanical, or Mechatronics Technology, with a minimum of 10 years of relevant experience in an FDA-regulated environment. · Proven hands-on experience in programming and design of Automation Systems and Track and Trace systems. · Demonstrated experience supporting control systems within a GMP-compliant pharmaceutical manufacturing environment. · A strong track record of successfully executing automation and control system projects in FDA-regulated manufacturing settings. · Solid unde
Key Responsibilities
2. Collaborate with stakeholders to gather requirements and define automation processes.
3. Provide technical guidance and mentoring to the automation development team.
4. Troubleshoot and resolve technical issues related to automation solutions.
5. Ensure compliance with best practices and standards in automation development.
6. Continuously assess and enhance the performance of automation solutions.
7. Identify opportunities for automation and drive the automation roadmap.
Skill Requirements
2. Proficiency in designing and implementing rpa solutions using automation anywhere.
3. Strong programming skills in scripting languages such as python, javascript, or vbscript.
4. Experience in end-to-end automation solution development lifecycle.
5. Excellent problem-solving and analytical abilities.
6. Strong communication and leadership skills to effectively lead a team.
7. Ability to work collaboratively with cross functional teams.
8. Knowledge of process improvement methodologies and best practices.