Senior Engineer, Biopharma Process Improvement (On-site PR)

ProQuality Network; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

ProQuality Network in Juncos, PR is seeking a Senior Engineer to independently lead process characterization, optimization, and troubleshooting across manufacturing, pilot plants, and capital projects. The selected candidate will apply advanced engineering principles to design and implement system modifications, experiments, and capital projects.

The ideal candidate will have hands-on biopharma experience and a proven ability to develop technical assessments, CAPAs, PM strategies, SOPs, and

Qualifications

• Bachelor’s degree in Chemical, Mechanical, or Electrical Engineering with hands-on biopharmaceutical manufacturing experience.
• Experience supporting manufacturing equipment and systems in a regulated pharmaceutical or biotechnology environment.
• Ability to independently conduct technical assessments, manage corrective actions, and lead equipment improvement initiatives.

Responsibilities

• Perform System Owner assessments and engineering impact assessments related to equipment failures, process deviations, and quality events.
• Support technical investigations, identifying equipment failure mechanisms, and developing CAPAs to minimize recurrence.
• Evaluating the applicability of CAPAs and lessons learned across other equipment, systems, and manufacturing areas.
• Managing engineering activities in IBM Maximo, including technical work order reviews and maintenance coordination.
• Developing and revising Preventive Maintenance (PM) strategies, Job Plans, inspection requirements, and SOPs.
• Implementing engineering controls and completing corrective actions associated with safety incidents and INCA records.
• Supporting equipment troubleshooting, repair coordination, obsolete equipment replacement, and modernization initiatives.
• Working with biopharmaceutical manufacturing equipment including centrifuges, autoclaves, tanks, chromatography, UF/DF systems, homogenizers, and related instrumentation.
• Preparing technical reports and assessment rationales with traceable documentation and timely actions.
• Collaborating with Manufacturing, Process Engineering, Maintenance, Quality, Automation, Validation, and suppliers.

Skills

Pharmaceutical manufacturing knowledge

CAPA and corrective actions

Technical report writing

Cross-functional collaboration

System Owner assessments

Education

Doctorate in Engineering

Master's degree in Engineering

Bachelor's degree in Engineering

Tools

IBM Maximo

Job description

ProQuality Network in Juncos, PR is seeking a Senior Engineer to independently lead process characterization, optimization, and troubleshooting across manufacturing, pilot plants, and capital projects. The selected candidate will apply advanced engineering principles to design and implement system modifications, experiments, and capital projects.

The ideal candidate will have hands-on biopharma experience and a proven ability to develop technical assessments, CAPAs, PM strategies, SOPs, and