BioPharma Consulting JAD Group

BioPharma Consulting JAD Group

·yesterday

Senior engineer - drug substance equipment and reliability

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Location

onsite, Juncos, Puerto Rico

Commitment

Full Time

Level

Senior (5+ years)

Required skills

Drug substance manufacturingEngineering impact assessmentsTechnical investigationsCAPAIBM MaximoPreventive maintenanceSOP developmentTroubleshootingEquipment modernizationCentrifugesAutoclavesChromatography systemsUF/DF systemsHomogenizersFilter integrity testingInstrumentation

Job Description

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.

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.

Contract: 6 months, with possible extension

Shift: Administrative, Monday–Friday

Ready to join the team?

Apply now