Senior Engineer - Drug Substance Equipment and Reliability

Own drug substance manufacturing equipment and systems at a leading biotechnology company in Juncos, Puerto Rico. Three openings.

What you'll do

• Perform system owner and engineering impact assessments for equipment failures, deviations and quality events.
• Support technical investigations, identify failure mechanisms and develop CAPAs; apply lessons learned across equipment and areas.
• Manage engineering work in IBM Maximo: work order technical review, pre- and post-approval, coordination and closure.
• Develop and revise preventive maintenance strategies, job plans, inspection requirements and SOPs.
• Lead troubleshooting, repairs, obsolete equipment replacement, spare parts evaluations and modernization projects.
• Implement engineering controls and actions for safety incidents.

Requirements

• Bachelor's in Chemical, Mechanical or Electrical Engineering + 4 years (or Master's + 2, or Doctorate).
• Manufacturing equipment support in pharma/biotech: centrifuges, autoclaves, process tanks, chromatography and UF/DF systems, homogenizers, filter integrity testers and instrumentation.
• Investigations, CAPA and technical report writing.
• IBM Maximo or similar CMMS.
• Able to manage multiple assignments and work with Manufacturing, Maintenance, Quality, Automation, Validation and suppliers.

Benefits

• Contract: 6 months, with possible extension
• Shift: Administrative, Monday–Friday