ISPV Inc.

Sr Engineer - 35760

Posted 4 Days Ago

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Juncos, PRI

In-Office

Senior level

Food • Professional Services • Business Intelligence • Pharmaceutical

The Role

Supports commercial pharmaceutical, biotechnology, medical-device, and combination-product manufacturing through process development, packaging operations, validation, investigations, and GMP quality-system activities. The role manages projects, troubleshoots packaging defects and equipment issues, authors technical documentation, analyzes process data, supports improvements and technology transfers, and collaborates with manufacturing, quality, engineering, validation, and regulatory teams.

Summary Generated by Built In

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.

Skills Required

Direct experience providing technical or process-development support to commercial pharmaceutical, biotechnology, medical-device, or combination-product manufacturing operations.
Experience managing projects.
Experience with sterile injectable products, prefilled syringes, autoinjectors, pens, or other drug-device combination products.
Direct knowledge of primary and secondary packaging, labeling, cartoning, and packaging-line troubleshooting.
Experience investigating inspection rejects, packaging defects, yield losses, equipment alarms, and process deviations using structured root-cause-analysis tools.
Experience authoring or reviewing technical protocols, study reports, engineering assessments, investigation reports, risk assessments, work instructions, and change controls.
Knowledge of process qualification and validation, including IQ/OQ/PQ, process performance qualification, test-method validation, and continued process verification or process monitoring.
Basic experience using statistical and data-analysis tools for trend analysis, control charts, process capability, variability assessments, and monitoring limits.
Direct experience with GMP-regulated manufacturing and quality-system processes, including deviations, CAPAs, nonconformances, complaints, change controls, and data integrity.
Experience collaborating with Manufacturing, Quality Assurance, Quality Control, Engineering, Validation, Maintenance, Automation, Supply Chain, and Regulatory Affairs.
Experience supporting process improvements, equipment upgrades, new product introductions, technology transfers, or new inspection and packaging technologies in a commercial environment.
Ability to provide effective on-floor support, communicate with operations personnel, and make timely data-driven technical decisions while maintaining compliance and product quality.
Doctorate in Engineering, or a master's degree plus at least two years of engineering experience, or a bachelor's degree in Engineering plus at least four years of engineering experience.