Job Title: Principal Automation Engineer – Packaging Systems
Location: Cork
Department: Engineering / Automation
Reports To: Site Automation Lead
Type: Full-Time on Site
About the Role
We are seeking a highly experienced Principal Automation Engineer with deep expertise in packaging automation for medical device manufacturing environments. This role is a senior technical leadership position responsible for driving innovation, optimization, and technical excellence in automated packaging systems.
Key Responsibilities
* Lead the design, development, and implementation of automated packaging systems, ensuring alignment with regulatory requirements (FDA, EU MDR, GAMP5).
* Serve as technical SME for packaging automation, guiding equipment selection, process integration, and lifecycle management for medical device and pharmaceutical packaging.
* Collaborate with cross-functional teams including manufacturing, quality, validation, and regulatory to ensure seamless project delivery.
* Provide strategic direction on automation technologies and system architectures for packaging lines, including robotics, vision systems, serialization, and material handling.
* Drive continuous improvement initiatives to enhance packaging system reliability, throughput, and cost-effectiveness.
* Lead or support the commissioning, qualification (IQ/OQ/PQ) and validation of new packaging systems.
* Mentor junior engineers, providing technical leadership and knowledge transfer.
* Ensure adherence to global and site-specific health, safety, and environmental policies in all project activities.
* Keep abreast of emerging trends in automation and packaging technologies and assess their application to current and future projects.
Qualifications
* Bachelor’s or Master’s degree in Engineering (Electrical, Mechanical, Mechatronics, Automation or related field).
* 15+ years of experience in medical device,, or highly regulated manufacturing environments.
* Proven track record leading automation projects with a strong focus on packaging lines—including thermoforming, sealing, labeling, cartoning, and vision inspection.
* Deep knowledge of PLC/HMI programming (e.g., Allen-Bradley, Siemens), SCADA, MES, and industry-standard automation protocols.
* Experience with regulated systems validation, including 21 CFR Part 11 compliance and GAMP methodologies.
* Excellent problem-solving, project management, and communication skills.
* Ability to work in a fast-paced, cross-functional team environment.
Preferred Experience
* Experience with robotic integration and vision-guided automation in packaging.
* Familiarity with serialization and traceability systems for med device packaging.
* Lean Six Sigma certification or experience in lean manufacturing environments.
* Experience working with CMOs and/or global project teams.
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