Sr Associate Manufacturing Systems at QRC Group, Inc

Juncos, Puerto Rico, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Mar, 26

Salary

0.0

Posted On

13 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

PLC Programming, Troubleshooting, VFD, Sensors, Vision Systems, Cognex, Keyence, Systech, ABB Robots, Fanuc Robots, Technical Support, Regulatory Compliance, Calibration, Quality Issues, Environmental Monitoring, Audit Program, Engineering Improvements

Industry

Staffing and Recruiting

Description

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. Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions! Job Description Sr Associate Manufacturing Systems with experience in PLC programmer and troubleshoot, 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.

Responsibilities

The Sr Associate Manufacturing Systems will evaluate and ensure compliance of utility systems and assist the maintenance team during regulatory inspections. They will also help develop and maintain an audit program and assist with engineering improvements.