Senior Pharma Equipment Engineer – Validation & Compliance

Integrated Services For Productivity & Validation, Inc; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Integrated Services For Productivity & Validation, Inc in Juncos, Puerto Rico seeks a licensed engineer to perform technical assessments of pharmaceutical equipment in regulated manufacturing environments.

Responsibilities include preparing and reviewing technical reports, supporting deviations and CAPAs, evaluating equipment design and lifecycle, and collaborating with cross-functional teams to ensure evidence-based conclusions and compliance with cGMP.

Qualifications

• Bachelor's in Engineering required with 4+ years of engineering experience.
• Experience in regulated pharma/biotech manufacturing environments preferred.
• Strong technical writing, problem-solving and communication skills.

Responsibilities

• Perform technical assessments of equipment in regulated pharma/biotech manufacturing environments.
• Prepare, review, and approve technical reports, engineering assessments, equipment evaluations, and technical justifications.
• Support deviations, investigations, CAPAs, change controls, risk assessments, and post-FDA commitments.
• Assess equipment design, functionality, reliability, lifecycle documentation, and maintenance strategies.
• Review engineering drawings, vendor documentation, and calibration records to support conclusions.
• Collaborate with Manufacturing, Maintenance, Automation, Validation, Quality, Process Development, and external vendors.

Skills

Technical writing

Problem-solving

Communication

Field inspection

Education

Bachelor's in Engineering

Job description

Integrated Services For Productivity & Validation, Inc in Juncos, Puerto Rico seeks a licensed engineer to perform technical assessments of pharmaceutical equipment in regulated manufacturing environments.

Responsibilities include preparing and reviewing technical reports, supporting deviations and CAPAs, evaluating equipment design and lifecycle, and collaborating with cross-functional teams to ensure evidence-based conclusions and compliance with cGMP.