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Sr Engineer - 35958
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
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.
- 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.