Senior Engineer - Drug Substance Equipment and Reliability

BioPharma Consulting JAD Group; Juncos (PR); Sur place; USD 70 000 - 100 000; Plein temps

Résumé du poste

BioPharma Consulting JAD Group in Puerto Rico seeks a contracted engineer to own and assess equipment, support investigations and drive CAPAs for pharma/biotech systems. You will manage Maximo work orders and develop preventive maintenance strategies while coordinating with Manufacturing, Quality and Suppliers.

The role requires an engineering degree and hands-on experience with process equipment, CAPA writing, and CMMS proficiency. 6-month contract, Monday–Friday administrative shift in Juncos.

Qualifications

• Bachelor's in Chemical, Mechanical or Electrical Engineering with 4+ years (or advanced degrees).
• Pharma/biotech equipment support including centrifuges, autoclaves, tanks, chromatography, UF/DF systems, homogenizers, testers and instrumentation.
• Experience in investigations, CAPA and technical report writing.
• IBM Maximo or similar CMMS experience.
• Ability to manage multiple assignments across Manufacturing, Maintenance, Quality, Automation, Validation and suppliers.

Responsabilités

• 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.

Connaissances

Pharma/Biotech equipment

CAPA investigations

CMMS (IBM Maximo)

Cross-functional collaboration

Maintenance planning

Formation

Engineering degree (Chemical/Mechanical/Electrical)

Outils

IBM Maximo

Description du poste

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