The Automation Engineer will be an integral part of a cross-functional team of engineers and technicians growing in size and responsibilities as the business needs increase.

In this visible and diverse role, you will provide hands-on production equipment support, troubleshooting, repairing and maintaining essential robotics and automation machinery. You will manage capital equipment and improvement projects, as well as work closely with vendors and contractors. You will also partner with QA on preparing and approving validation and other documents and procedures essential for regulatory compliance.

Responsibilities:

• Provide hands-on engineering support, troubleshooting and maintenance of robotic and automated HMLV production floor equipment in a regulated environment.
• Define, procure and support robotic and automated filling, labeling and packaging equipment (SOW, Functional Spec., FAT, SAT)
• Apply Project Management skills and tools to lead and support capital equipment and improvement projects.
• Resolve equipment failures with a focus on root cause(s). Lead and assist with defining and implementing corrective and preventive actions, and resolution to audit findings.
• Prepare, complete and support validations (IQ/OQ/PQ) to meet applicable FDA and regulatory requirements.

Job Summary