Validation Engineer
Fusion Life Sciences Technologies LLC
Job Title: Equipment Validation Engineer
Location: Boston, MA
Experience: 3–5 Years
Work Mode: Onsite
Key Responsibilities
- Develop, write, and execute IQ/OQ/PQ protocols for manufacturing equipment.
- Perform equipment qualification for CNC machines and precision manufacturing equipment.
- Prepare validation plans, test procedures, and final qualification reports.
- Investigate deviations and support CAPA and troubleshooting activities.
- Maintain GMP/GDP-compliant documentation and collaborate with Quality and Manufacturing Engineering teams.
Must-Have Skills
- 3–5 years of equipment qualification or validation experience.
- Hands-on IQ/OQ/PQ protocol writing and execution.
- Manufacturing equipment qualification experience.
- Validation documentation and report preparation.
- Knowledge of GMP, GDP, deviations, and quality systems.
Preferred Qualifications
- Medical device manufacturing experience.
- CNC machine qualification experience.
- Pharmaceutical or combination product manufacturing experience.
- Knowledge of risk assessments, change control, and CAPA.
Vacancy posted 12 hours ago
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