Sterility Engineer III

Support the Cork Sterilization team to optimize operations, ensure regulatory compliance, and maintain validation standards. Lead technical activities resulting in new or improved sterilization processes aligned with strategic goals. Analyze complex problems using advanced engineering principles, proposing novel solutions and driving implementation. Collaborate with R&D and NPD teams to integrate new products and technologies into existing sterilization platforms. Monitor equipment, tools, and process parameters to ensure conformance and identify areas for improvement. Lead or support validations, especially for autoclaves and pharmaceutical systems. Cultivate cross-functional relationships and networks to support efficient task completion and continuous improvement. Mentor team members by sharing technical expertise and providing guidance on best practices. Ensure adequate backup capacity is maintained for sterilization processes, including coordination with external contractors. Operate effectively within both pharmaceutical and medical device quality systems. Level 8 Honors Bachelor's degree in Engineering or a related technical field. (STEM) Minimum of 4 years' experience in a regulated manufacturing environment, ideally with exposure to sterilization processes. Demonstrated expertise in validation, with preference for pharmaceutical and/or autoclave validation experience. Strong understanding of engineering principles, quality systems, and regulatory requirements (e.g., FDA, ISO). Excellent problem-solving, communication, and cross-functional collaboration skills.