About this role
Sr Engineer with experience supporting manufacturing equipment and systems in a regulated pharmaceutical or biotechnology environment, with the ability to independently manage technical assessments, corrective actions, and equipment improvement initiatives.
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Performing System Owner assessments and engineering impact assessments related to equipment failures, process deviations, and quality events.
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Supporting technical investigations, identifying equipment failure mechanisms, and developing corrective and preventive actions to reduce recurrence.
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Evaluating the applicability of CAPA and lessons learned to other equipment, systems, and manufacturing areas.
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Managing engineering activities in IBM Maximo, including work order technical review, pre-approval and post-approval activities, maintenance coordination, and follow-up through closure.
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Developing and revising preventive maintenance strategies, Job Plans, inspection requirements, and SOPs.
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Implementing engineering controls and completing actions associated with safety incidents and INCA records.
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Supporting equipment troubleshooting, repair coordination, replacement of obsolete equipment, spare parts evaluations, and equipment modernization projects.
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Working with bio pharmaceutical manufacturing equipment such as centrifuges, autoclaves, process tanks, chromatography and UF/DF systems, homogenizes, filter integrity testers, and associated instrumentation.
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Preparing clear technical reports and assessment rationales, maintaining traceable supporting documentation, and completing actions within established deadlines.
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Coordinating with Manufacturing, Process Engineering, Maintenance, Quality, Automation, Validation, and equipment suppliers.
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Managing multiple concurrent assignments and prioritizing work according to safety, quality, and operational needs..
Requirements
- Doctorate or Masters + 2 years of Engineering experience or
- Bachelors in Engineering + 4 years of Engineering experience (Chemical, Mechanical or Electrical Engineer)
- Bilingual (Spanish/English)