Position SummaryWe 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.
