JT846 - SR. ASSOCIATE MANUFACTURING SYSTEMS

Juncos, Puerto Rico
Temporary
Biopharmaceutical
Experienced

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
  • Experience in PLC programmer and troubleshoot, VFD, Sensors, Vision systems like Cognex, Keyence or Systech and knowledge of ABB or Fanuc robots.
  • Comprehensive understanding of validation protocol requirements
  • Technical (Equipment Specific)
  • 12 hrs. shifts

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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