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Automation and Robotics Engineer
2 months ago
Be part of a transformative journey in Precision Medicine. Our goal is to enhance human health by leveraging precision medicine across laboratories, partners, and patients worldwide.
Within the Diagnostics and Genomics Group (DGG), our Manufacturing Engineering team collaborates closely with various departments in the Order Fulfillment and Supply Chain (OFS) to facilitate the production of highly regulated medical devices essential for healthcare providers in selecting appropriate therapies for their patients.
Join a dedicated engineering team that plays a crucial role in supporting Finished Production. Our team members are deeply committed to their work, as it directly impacts patients battling cancer.
Reporting to the Engineering Manager, you will be a vital member of a cross-functional team of engineers and technicians, expanding in size and responsibilities as business demands grow.
In this prominent and diverse role, you will provide hands-on support for production equipment, including troubleshooting, repairing, and maintaining critical robotics and automation machinery. You will oversee capital equipment and improvement projects while collaborating closely with vendors and contractors. Additionally, you will work alongside Quality Assurance to prepare and validate essential documentation and procedures necessary for regulatory compliance.
Key Responsibilities
- Deliver hands-on engineering support, troubleshooting, and maintenance of robotic and automated production floor equipment in a regulated setting.
- Define, procure, and support robotic and automated filling, labeling, and packaging equipment (including SOW, Functional Spec., FAT, SAT).
- Utilize project management skills to lead and support capital equipment and enhancement projects.
- Diagnose equipment failures with a focus on root causes. Lead and assist in defining and implementing corrective and preventive actions (CAPA) and addressing audit findings (NCR, SCAR, etc.).
- Prepare, complete, and support validations (IQ/OQ/PQ/SQ) to comply with applicable FDA and regulatory standards.
- Promote continuous improvement initiatives to enhance product quality and reduce manufacturing costs.
Required Knowledge, Skills & Abilities
- Bachelor's Degree in Mechanical, Electrical, Robotics, Automation, or other relevant Engineering & Technology disciplines with 4+ years of experience, or an equivalent combination of education and experience.
- Hands-on experience with Automation and Robotics, PLCs, and HMIs.
- Experience in maintaining robotic and automated equipment.
- Familiarity with process/equipment validation, including documentation and execution - IQ, OQ, PQ.
- Strong technical, project management, and documentation skills.
- Self-motivated, highly organized, complex problem solver with a detail-oriented mindset and strong analytical and communication skills.
- Proven ability to work in a regulated environment.
- Understanding of FDA QSR requirements, ISO 13485, or other recognized international quality system standards.
- Experience working with and/or managing suppliers and subcontractors.
- Knowledge of DI water systems, cold room management, and central monitoring systems.
- Experience with FMEA, DOE, and SPC.
- Proficiency in CAD, SolidWorks, and Siemens NX.
- Familiarity with SAP, Agile, Electronic Batch Records (EBR), Manufacturing Execution Systems (MES), and SCADA.
- Hands-on experience programming Fanuc and Denso robots, Omron, Allen Bradley PLCs, HMIs, Cognex Vision Systems, Zebra, and Sato Labelers.
- Knowledge of Industry 4.0, AI, predictive analytics, Machine Learning, Data Science, and touchless transactions.
Occasional
Work Schedule
Full-time
Shift
Day
Job Function
Manufacturing