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We are seeking a Sr. Engineer with:
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, autoinjectors, 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, nonconformances, 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.
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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
- Education:Â Doctorate or Masters + 2 years of Engineering experience or Bachelors in Engineering + 4 years of Engineering experience.
- Fully Bilingual (English & Spanish)
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