Senior Process Engineer - Pharma Packaging & Validation

Integrated Services for Productivity & Validation, Inc; Juncos (PR); On-site; USD 85,000 - 130,000; Full time

Job summary

Integrated Services For Productivity & Validation, Inc in Juncos, Puerto Rico, seeks an engineering professional to provide technical and process-development support for pharmaceutical, biotech, medical-device, or combination-product manufacturing operations. The role emphasizes project management, validation activities, and cross-functional collaboration within a GMP environment.

The ideal candidate will have a Doctorate or Master’s in Engineering with several years of engineering experience,

Qualifications

• Requires doctoral or master’s level engineering expertise with several years of related engineering experience.
• Experience with sterile products, packaging, and device combinations.
• Knowledge of GMP-regulated manufacturing, quality systems, deviations, CAPAs, nonconformances, and change controls.
• Experience authoring or reviewing technical protocols, study reports, and validation documents.

Responsibilities

• Provide technical and process-development support to manufacturing operations.
• Manage projects and coordinate cross-functional teams.
• Investigate packaging defects, yields, and process deviations using root-cause analysis.
• Support qualification/validation activities (IQ/OQ/PQ, PT/PPQ, method validation).
• Analyze process data using trend analysis and control charts to monitor performance.
• Collaborate with Manufacturing, QA, QC, Engineering, Validation, and Regulatory Affairs.

Skills

Project management

Technical/process development

Sterile injectable knowledge

Packaging operations knowledge

Root-cause analysis

Documentation writing

Validation activities

Data analysis

GMP/regulatory knowledge

Cross-functional collaboration

Process improvement

On-floor technical support

Education

Doctorate in Engineering

Master’s in Engineering

Bachelor’s in Engineering

Job description

Integrated Services For Productivity & Validation, Inc in Juncos, Puerto Rico, seeks an engineering professional to provide technical and process-development support for pharmaceutical, biotech, medical-device, or combination-product manufacturing operations. The role emphasizes project management, validation activities, and cross-functional collaboration within a GMP environment.

The ideal candidate will have a Doctorate or Master’s in Engineering with several years of engineering experience,