The Judge Group - New Albany, IN
posted 5 months ago
The Associate Manufacturing Systems Engineer will play a crucial role in supporting the engineering and operational functions within the manufacturing environment. This position is primarily focused on providing technical support for various engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical, and process automation issues. The engineer will be involved in coordinating technical support efforts and ensuring that all activities comply with relevant regulations and standards, including the Code of Federal Regulations (CFRs) and current Good Manufacturing Practices (cGMPs). In addition to technical support, the Associate Engineer will assist during regulatory agency inspections, providing necessary documentation and technical responses to inquiries from the FDA and other regulatory bodies. The role also includes completing advanced maintenance activities and operating sophisticated plant support equipment, ensuring that all operations are conducted in accordance with established Standard Operating Procedures (SOPs) and job plans. The engineer will be expected to investigate complex issues or problems, leveraging the mentorship of experienced staff to develop effective solutions. Another key responsibility will be to assist the team in maintaining an up-to-date spare parts inventory system for the equipment and systems under their purview. This includes evaluating current maintenance procedures and recommending changes to optimize the maintenance program, troubleshooting, and repairing equipment and system failures. The engineer will also interpret and review various technical documents, including utility and process system plans, plumbing, ductwork plans, architectural layouts, and HVAC P&IDs. The position requires flexibility in working hours, as the engineer will support operations during non-standard shifts, which may include weekends and holidays. The initial work schedule will be first shift (Monday through Friday, approximately 6:30 am to 3 pm) before transitioning to an off-shift schedule (6 pm to 6 am).