Senior Biopharma Process Engineer - On-Site PR

ProQualityNetwork; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

ProQualityNetwork in Juncos, PR seeks a Senior Engineer to independently lead process characterization, optimization strategies, and troubleshoot operational issues across manufacturing, pilot plant, and capital projects.

The selected candidate will apply advanced engineering principles to design and implement system modifications, run experiments, and develop technical assessments with recommendations to improve safety, quality, and efficiency. This role is on-site and contract for 6 months.

Qualifications

• Bachelor’s degree in Chemical, Mechanical, or Electrical Engineering with hands-on biopharma experience
• Experience in regulated pharmaceutical/biotechnology environments
• Ability to independently conduct technical assessments and lead equipment improvements
• Experience supporting manufacturing equipment and systems in regulated settings

Responsibilities

• Perform system owner assessments and engineering impact assessments related to equipment failures, deviations, and quality events
• Support technical investigations, identify failure mechanisms, and develop CAPAs to minimize recurrences
• Evaluate applicability of CAPAs and lessons learned across equipment, systems, and manufacturing areas
• Manage engineering activities in IBM Maximo including work order reviews, pre/post-approval actions, maintenance coordination, and closure
• Develop and revise PM strategies, job plans, inspection requirements, and SOPs
• Implement engineering controls and complete corrective actions for safety incidents and INCA records

Skills

System Owner assessments

CAPA management

Troubleshooting

Cross-functional collaboration

PM strategies

Documentation & GMP knowledge

Process instrumentation

Education

Doctorate in Engineering

Master’s degree in Engineering (2+ years)

Bachelor’s degree in Engineering (4+ years)

Tools

IBM Maximo

Job description

ProQualityNetwork in Juncos, PR seeks a Senior Engineer to independently lead process characterization, optimization strategies, and troubleshoot operational issues across manufacturing, pilot plant, and capital projects.

The selected candidate will apply advanced engineering principles to design and implement system modifications, run experiments, and develop technical assessments with recommendations to improve safety, quality, and efficiency. This role is on-site and contract for 6 months.