<p>Fully onsite New Albany, OH</p> <p>Shift details: Administrative shift 8am - 5pm M-F for approximately first 2-4 months</p> <p>6pm - 6am thereafter (graves 15% shift differential)</p> <p>In this role, you will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications. You will evaluate and determine if utility systems, process maintenance, instrumentation/ calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area in Non-Standard Shifts structure.</p> <p>Take part in the coordination of tech support on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical, and process automation issues.</p> <p>Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.</p> <p>Support cGMP validation of equipment and processes.</p> <p>Complete advanced maintenance activities or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans, and Client policies.</p> <p>Investigate complex issues or problems through the mentorship of experienced staff.</p> <p>Assist the team with maintaining an up-to-date working spare parts inventory system for equipment/systems.</p> <p>Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program troubleshoot and repair equipment/system failures.</p> <p>Interpret and review utility, process system/equipment, plumbing, ductwork plans, architectural, and HVAC P&ID's.</p> <p>Support Operations using Current Good Manufacturing Practices (cGMP).</p> <p>Support Operations in non-standard shifts that include weekends and/or holidays as determined by the business.</p>