JT751 - SR. ASSOCIATE MANUFACTURING SYSTEMS
About The Position
Quality Consulting Group is seeking a motivated Sr. Associate Manufacturing Systems professional to provide technical engineering support for automation and manufacturing systems in the pharmaceutical, biotech, medical device, and manufacturing industries. The role supports optimization strategies, upgrades, replacements, and modifications, and helps ensure maintenance operations comply with corporate policies, industry and regulatory standards, and FDA requirements. The position also supports maintenance-team training, procedures, regulatory and compliance activities, investigations, audits, engineering improvements, and testing of proposed sanitization and maintenance procedure changes for process, utility, and clean room systems. The role assists with regulatory inspections and responses, and supports responses to high-purity water system and environmental monitoring alerts and actions.
Requirements
- Bachelor's degree in Engineering or a related area.
- At least 2 years of engineering or automation experience.
- Experience with recipe entry in packaging equipment, automation assessment to determine appropriate recipe parameters, and the Systech System.
- Knowledge of troubleshooting Rockwell PLC systems.
- Knowledge of troubleshooting and adjusting Cognex vision systems.
- Knowledge of cGMPs.
- Knowledge of basic control systems hardware.
Responsibilities
- Provide technical engineering support for system and equipment optimization strategies, upgrades, replacements, and modifications.
- Help ensure maintenance-team operations and activities comply with corporate policies, industry standards, regulatory standards, and FDA standards.
- Evaluate whether utility systems, process maintenance, instrumentation, calibration and electrical systems, and technical cleaning systems meet applicable standards and requirements.
- Ensure the maintenance-team training program, standard operating procedures, and equipment and system operational standards are consistent throughout the team.
- Coordinate technical support for maintenance-team engineering, regulatory, compliance, calibration, quality, microbial and environmental, technical cleaning, validation, electrical, and process maintenance issues.
- Assist the maintenance team during FDA and other regulatory agency inspections and provide technical support in response to those agencies.
- Assist the maintenance team in responding to high-purity water system and environmental monitoring alert/action notifications.
- Assist with investigations of alert/action notifications.
- Assist with developing and maintaining a maintenance-team audit program and facilitate routine audits of activities, documentation, operations, and related areas.
- Assist plant engineering in evaluating and implementing engineering improvements, policy changes, compliance improvements, and optimization programs.
- Assist with testing proposed sanitization and maintenance procedure changes and modifications for process, utility, and clean room systems.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
