Sr Engineer - 35760

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 | Contract

Juncos, Puerto Rico | Posted on 09/16/2026

We provide the industry with a platform of solutions designed to their actual needs. We share and implement leading edge technology and methods that exceed customer expectation and deliver a one-stop provider of services focus on the well-being of the company and the employees.

Job Description

• 1. Direct experience providing technical or process-development support to commercial pharmaceutical, biotechnology, medical-device, or combination-product manufacturing operations.
• 2. Experience managing projects
• 3. Experience with sterile injectable products, prefilled syringes, auto injectors, pens, or other drug-device combination products.
• 4. Direct knowledge of packaging operations, including primary and secondary packaging, labeling, cartoning, and packaging-line troubleshooting.
• 5. Proven ability to investigate inspection rejects, packaging defects, yield losses, equipment alarms, and process deviations using structured root-cause-analysis tools.
• 6. Experience authoring or reviewing technical protocols, study reports, engineering assessments, investigation reports, risk assessments, work instructions, and change controls.
• 7. Knowledge of process qualification and validation activities, including equipment qualification (IQ/OQ/PQ), process performance qualification, test-method validation, and continued process verification or process monitoring.
• 8. Basic experience using statistical and data-analysis tools to assess process performance, including trend analysis, control charts, process capability, variability assessments, and establishment of monitoring limits.
• 9. Direct experience with GMP-regulated manufacturing and quality-system processes, including deviations, CAPAs, non conformances, complaints, change controls, and data-integrity requirements.
• 10. Experience collaborating cross-functionally with Manufacturing, Quality Assurance, Quality Control, Engineering, Validation, Maintenance, Automation, Supply Chain, and Regulatory Affairs.
• 11. Experience supporting process improvements, equipment upgrades, new product introductions, technology transfers, or implementation of new inspection and packaging technologies in a commercial environment.
• 12. Ability to provide effective on-the-floor support, communicate clearly with operations personnel, and make timely, data-driven technical decisions while maintaining compliance and product quality.

Requirements

Doctorate OR Masters + 2 years of Engineering experience OR

Bachelors in Engineering + 4 years of Engineering experience.