JT046 - SR. ASSOCIATE MANUFACTURING SYSTEMS at Quality Consulting Group

Juncos, Puerto Rico, United States -

Full Time

Start Date

Immediate

Expiry Date

27 Jun, 26

Salary

0.0

Posted On

29 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Automation, System Optimization, cGMPs, PLC Systems, Rockwell, Vision Systems, Cognex, Systech Vision System, Control Systems Hardware, Regulatory Compliance, FDA Standards, Technical Engineering Support, Maintenance Team Training, Audit Program Development, Validation Issues, Electrical Issues

Industry

Outsourcing and Offshoring Consulting

Description

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA. Responsibilities: Full Automation role will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications and ensure that all of the maintenance team operations and activities are maintained in compliance with respect to current corporate policies, industry standards, regulatory standards and FDA standards. 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: Bachelor's degree in related area 2 years of Engineering or Automation experience Knowledge on PLC Systems Trobleshooting– Rockwell Knowledge on Vision Systems Trobleshooting/Adjustment– Cognex Knowledge on cGMP’s Knowledge on Systech Vision System Trobleshooting\Adjustments. Nice to have - Work experience on FDA regulated industries. Knowledge on basic control systems hardware. Could be assigned to any of the four shift A, B C and D. Availability to 5 am – 5:30 pm and/or 5 pm – 5:30 am Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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Responsibilities

This role provides technical engineering support for system optimization, upgrades, and modifications, ensuring all maintenance operations comply with corporate, industry, regulatory, and FDA standards. Responsibilities also include coordinating technical support for engineering and compliance issues and assisting the maintenance team during regulatory inspections.