Sr Engineer - 35958

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 is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.

Position Summary

We are seeking a highly motivated Senior Engineer to support manufacturing equipment reliability, performance, and continuous improvement initiatives within a regulated pharmaceutical or biotechnology manufacturing environment. The successful candidate will serve as a technical leader responsible for equipment assessments, investigations, CAPA implementation, maintenance strategy optimization, and cross-functional engineering support. This role requires strong technical expertise, independent decision-making, and the ability to manage multiple priorities while ensuring compliance with safety, quality, and operational requirements.

Key Responsibilities

• Performing System Owner assessments and engineering impact assessments related to equipment failures, process deviations, and quality events.
• Supporting technical investigations, identifying equipment failure mechanisms, and developing corrective and preventive actions to reduce recurrence.
• Evaluating the applicability of CAPA and lessons learned to other equipment, systems, and manufacturing areas.
• Managing engineering activities in IBM Maximo, including work order technical review, pre-approval and post-approval activities, maintenance coordination, and follow-up through closure.
• Developing and revising preventive maintenance strategies, Job Plans, inspection requirements, and SOPs.
• Implementing engineering controls and completing actions associated with safety incidents and INCA records.
• Supporting equipment troubleshooting, repair coordination, replacement of obsolete equipment, spare parts evaluations, and equipment modernization projects.
• Working with biopharmaceutical manufacturing equipment such as centrifuges, autoclaves, process tanks, chromatography and UF/DF systems, homogenizers, filter integrity testers, and associated instrumentation.
• Preparing clear technical reports and assessment rationales, maintaining traceable supporting documentation, and completing actions within established deadlines.
• Coordinating with Manufacturing, Process Engineering, Maintenance, Quality, Automation, Validation, and equipment suppliers.
• Managing multiple concurrent assignments and prioritizing work according to safety, quality, and operational needs.

Minimum Qualifications

• Doctorate degree in Engineering; OR
• Master's degree in Engineering with a minimum of 2 years of engineering experience; OR
• Bachelor's degree in Chemical, Mechanical, or Electrical Engineering with a minimum of 4 years of engineering experience.
• Experience supporting manufacturing equipment and systems within a regulated pharmaceutical, biotechnology, or life sciences environment.
• Strong knowledge of equipment reliability, troubleshooting, maintenance strategies, and engineering investigations.
• Experience working within quality systems, CAPA processes, deviation management, and change control programs.
• Ability to independently manage technical assessments and engineering projects.

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.