Senior Engineer, Pharma Equipment Reliability & CAPA

Mirus Consulting Group; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

mîrus Consulting Group seeks a Senior Engineer to enhance equipment reliability, performance, and continuous improvement in a regulated pharma/biotech setting. You will lead assessments, CAPA activities, and maintenance strategy optimization across multi-disciplinary teams.

Join a local Puerto Rico firm focused on validation and IT consulting for pharmaceutical clients, with opportunities to influence safety, quality, and operational excellence in a dynamic environment.

Qualifications

• Doctorate or Master’s degree in Engineering with experience in regulated pharma/biotech environments.
• Bachelor’s degree in Chemical, Mechanical, or Electrical Engineering with 4+ years in regulated settings.

Responsibilities

• Perform System Owner assessments and engineering impact assessments related to equipment failures and quality events.
• Support technical investigations and CAPA implementation to reduce recurrence.
• Evaluate applicability of CAPA and lessons learned to other equipment and areas.
• Manage engineering activities in IBM Maximo, including work order reviews and maintenance coordination.
• Develop and revise preventive maintenance strategies, Job Plans, and SOPs.
• Implement engineering controls and complete actions from safety incidents and INCA records.
• Support equipment troubleshooting, repair coordination, and modernization projects.
• Collaborate with Manufacturing, Process Engineering, Maintenance, Quality, Automation, Validation, and suppliers.
• Prepare clear technical reports and maintain traceable documentation.
• Prioritize multiple assignments to meet safety, quality, and operational deadlines.

Skills

Equipment reliability

Troubleshooting

Maintenance strategy

CAPA processes

Deviation management

Change control

Project management

Education

Doctorate in Engineering

Master's in Engineering

Bachelor's in Chemical, Mechanical, or Electrical Engineering

Tools

IBM Maximo

Job description

mîrus Consulting Group seeks a Senior Engineer to enhance equipment reliability, performance, and continuous improvement in a regulated pharma/biotech setting. You will lead assessments, CAPA activities, and maintenance strategy optimization across multi-disciplinary teams.

Join a local Puerto Rico firm focused on validation and IT consulting for pharmaceutical clients, with opportunities to influence safety, quality, and operational excellence in a dynamic environment.