QRC
QRC Group, LLC is a firm dedicated to offering services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Sr Associate Manufacturing Systems
with experience in PLC programming and troubleshooting, VFD, sensors, vision systems such as Cognex, Keyence or Systech and knowledge of ABB or Fanuc robots.
Responsibilities
Evaluate and determine if utility systems, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry, regulatory, and FDA standards.
Ensure the maintenance team training program, SOPs, and equipment/system operational standards are consistent throughout the team.
Participate in the coordination of technical support to the maintenance team on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical, and process maintenance issues.
Assist the maintenance team during FDA and other regulatory agency inspections. Provide technical support to the maintenance team in response to the FDA and other regulatory agencies.
Assist the maintenance team when responding to high‑purity water systems and environmental monitoring alert/action notifications. Investigate all alert/action notifications.
Assist with the development and maintenance of an audit program for the maintenance team and facilitate routine audits of activities, documentation, operations, and related areas to ensure continued compliance.
Assist plant engineering in the evaluation and implementation of engineering improvements, policy changes, compliance improvements and optimization programs.
Assist with the testing of proposed sanitization and maintenance procedure changes and modifications for process, utility and clean‑room systems.
Qualifications
Master’s degree or Bachelor’s degree and 2 years of engineering experience, or Associate’s degree and 6 years of engineering experience.
Bilingual (Spanish/English) – write and speak.
Availability to work a 12‑hour shift.
All your information will be kept confidential according to EEO guidelines.
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Sr Associate Manufacturing Systems
with experience in PLC programming and troubleshooting, VFD, sensors, vision systems such as Cognex, Keyence or Systech and knowledge of ABB or Fanuc robots.
Responsibilities
Evaluate and determine if utility systems, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry, regulatory, and FDA standards.
Ensure the maintenance team training program, SOPs, and equipment/system operational standards are consistent throughout the team.
Participate in the coordination of technical support to the maintenance team on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical, and process maintenance issues.
Assist the maintenance team during FDA and other regulatory agency inspections. Provide technical support to the maintenance team in response to the FDA and other regulatory agencies.
Assist the maintenance team when responding to high‑purity water systems and environmental monitoring alert/action notifications. Investigate all alert/action notifications.
Assist with the development and maintenance of an audit program for the maintenance team and facilitate routine audits of activities, documentation, operations, and related areas to ensure continued compliance.
Assist plant engineering in the evaluation and implementation of engineering improvements, policy changes, compliance improvements and optimization programs.
Assist with the testing of proposed sanitization and maintenance procedure changes and modifications for process, utility and clean‑room systems.
Qualifications
Master’s degree or Bachelor’s degree and 2 years of engineering experience, or Associate’s degree and 6 years of engineering experience.
Bilingual (Spanish/English) – write and speak.
Availability to work a 12‑hour shift.
All your information will be kept confidential according to EEO guidelines.
#J-18808-Ljbffr