Sr. Associate Mfg Systems

The Senior Associate, Manufacturing Systems provides technical engineering support for system and equipment optimization, upgrades, replacements, and modifications, ensuring maintenance operations comply with corporate policies, industry standards, regulatory guidelines, and FDA requirements.

Requirements

• Evaluate and ensure utility systems, process maintenance, instrumentation/calibration/electrical systems, and technical cleaning systems meet all applicable industry, regulatory, and FDA standards.
• Maintain consistency in the maintenance team’s training program, standard operating procedures (SOPs), and equipment/system operational standards.
• Provide technical guidance to the maintenance team on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical, and process maintenance issues.
• Participate in system optimization strategies, equipment upgrades, and process improvements.
• Support testing and implementation of sanitization and maintenance procedure changes for process, utility, and clean room systems.
• Assist the maintenance team during FDA and other regulatory inspections.
• Provide technical support in preparing responses to regulatory observations and requests.
• Support investigations into high purity water systems and environmental monitoring alert/action notifications.
• Partner with plant engineering to implement engineering improvements, compliance enhancements, and equipment optimization projects.
• Facilitate routine audits and documentation reviews to maintain a state of control.

Benefits

• 3-year contract
• 12 hours shift
• 48 hours a week