Sr Engineer

QRC Group•Juncos, PR

About The Position

The Sr Engineer supports manufacturing equipment and systems in a regulated pharmaceutical or biotechnology environment. The role independently manages technical assessments, corrective actions, and equipment improvement initiatives. It works across manufacturing and support functions to investigate equipment issues, maintain equipment strategies and documentation, and complete engineering actions within established deadlines.

Requirements

  • Doctorate, or a master's degree plus 2 years of engineering experience.
  • Bachelor's degree in Engineering plus 4 years of engineering experience; fields specified are Chemical, Mechanical, or Electrical Engineering.
  • Bilingual in Spanish and English.

Responsibilities

  • Perform System Owner assessments and engineering impact assessments related to equipment failures, process deviations, and quality events.
  • Support technical investigations, identify equipment failure mechanisms, and develop corrective and preventive actions to reduce recurrence.
  • Evaluate whether CAPAs and lessons learned apply to other equipment, systems, and manufacturing areas.
  • Manage engineering activities in IBM Maximo, including work order technical review, pre-approval and post-approval activities, maintenance coordination, and follow-up through closure.
  • Develop and revise preventive maintenance strategies, Job Plans, inspection requirements, and SOPs.
  • Implement engineering controls and complete actions associated with safety incidents and INCA records.
  • Support equipment troubleshooting and repair coordination, replacement of obsolete equipment, spare parts evaluations, and equipment modernization projects.
  • Prepare clear technical reports and assessment rationales, maintain traceable supporting documentation, and complete actions within established deadlines.
  • Coordinate with Manufacturing, Process Engineering, Maintenance, Quality, Automation, Validation, and equipment suppliers.
  • Manage multiple concurrent assignments and prioritize work according to safety, quality, and operational needs.
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