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Sr Engineer 35760

Integrated Services For Productivity & Validation, Inc

Job Location:

Juncos - Puerto Rico

Monthly Salary: Not provided by the employer

Experience Required: 4-5years

Posted: 17 September 2026 (Yesterday)

Application Deadline: 15 December 2026

Vacancies: 1 Vacancy

Job Summary

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.

Required Skills:

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.

Required Education:

Doctorate OR Masters 2 years of Engineering experience OR Bachelors in Engineering 4 years of Engineering experience.

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