Equipment Engineer - P2

Revalidate automated production lines to ensure compliance with industry standards and regulations. Develop and execute validation protocols (IQ/OQ/PQ) for equipment. Maintain detailed and accurate documentation of validation activities. Collaborate with cross-functional teams to ensure validation requirements and timeline are met. Troubleshoot and resolve validation issues in a timely manner. Ensure all validation activities are conducted in accordance with company policies and procedures. Responsible for the introduction and validation of new equipment. Works with Value Streams to identify opportunities for equipment improvement - automation, vision systems, robotics etc. Works with Product Development to help establish the equipment requirements for new products. Meets with vendors to review equipment proposals, vendor selection and capital approval. A core team member for new equipment design reviews and FAT's. Transfer and validation of equipment from other sites. Helps debug production issues with automated equipment. Champions the introduction of new technologies. Provides input and helps in selection of new technologies to improve plant efficiencies. Initiates cross-functional partnerships to identify and resolve production/engineering issues. Establishes and supports a work environment of continuous improvement that supports Quality policy, Quality System & the appropriate regulations for the area. Maintain and develop the team's technical and trouble shooting skills. Manage the planning and execution of equipment validations per E&AS requirements. Providing technical leadership on maintenance and equipment issues. Bachelor's degree in Engineering, Science, or a related field. Proven experience in validation within the medical device or pharmaceutical industry. Familiarity with automated production equipment, including Cognex and Keyence vision systems, Epson and UR robots. Strong documentation and technical writing skills. Problem-solving and analytical skills. Ability to work independently and as part of a team. Experience with software validation. Knowledge of Allen Bradley PLCs. Understanding of regulatory requirements (e.g., FDA).