QRC
Company Description
QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Job Description Sr Associate Manufacturing Systems
with experience in PLC programmer and troubleshooting, VFD, Sensors, Vision systems like Cognex, Keyence or Systech and knowledge of ABB or Fanuc robots.
Functions
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.
Ensure the maintenance team training program, standard operating procedures and equipment/system operational standards are consistent throughout the team.
Participate in the coordination of technical support to the maintenance team on engineering issues, regulatory issues, compliance issues, calibration issues, quality issues, microbial/environmental issues, technical cleaning issues, validation issues, electrical issues 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. Assist with the investigation on 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 a continued state of 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/Speak)
Availability to work 12 hour shift
Additional Information All your information will be kept confidential according to EEO guidelines.
Seniority Level Executive
Employment Type Contract
Job Function Purchasing and Supply Chain
Industries Technology, Information and Internet
#J-18808-Ljbffr
Job Description Sr Associate Manufacturing Systems
with experience in PLC programmer and troubleshooting, VFD, Sensors, Vision systems like Cognex, Keyence or Systech and knowledge of ABB or Fanuc robots.
Functions
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.
Ensure the maintenance team training program, standard operating procedures and equipment/system operational standards are consistent throughout the team.
Participate in the coordination of technical support to the maintenance team on engineering issues, regulatory issues, compliance issues, calibration issues, quality issues, microbial/environmental issues, technical cleaning issues, validation issues, electrical issues 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. Assist with the investigation on 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 a continued state of 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/Speak)
Availability to work 12 hour shift
Additional Information All your information will be kept confidential according to EEO guidelines.
Seniority Level Executive
Employment Type Contract
Job Function Purchasing and Supply Chain
Industries Technology, Information and Internet
#J-18808-Ljbffr