Sr. Engineer 35958

Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.

• Experience supporting manufacturing equipment and systems in a regulated pharmaceutical or biotechnology environment.
• Ability to independently manage technical assessments, corrective actions, and equipment improvement initiatives.
• Experience in Medical Device or Pharma
• Bilingual (English/Spanish)

• →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 OR Masters + 2 years of Engineering experience OR bachelor’s in engineering + 4 years of Engineering experience.