About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About this role

Provide hands-on execution support for data collection, analysis, documentation, and shop-floor activities during process development and pre-validation.

What You'll Do

1. Data Collection & Analysis Support

• Execute data collection for development builds, TMV studies, and process characterization.
• Perform basic statistical analysis (trend charts, Cp/Cpk calculations, GR&R data preparation).
• Maintain organized datasets and ensure traceability to lots, builds, and equipment.

2. TMV / MSA Execution

• Support measurement system studies by:
• • Coordinating sample preparation and measurement runs
  • Collecting and organizing TMV/GR&R data
• Document results and deviations for review by the Senior Quality Engineer.

3. Pre-Validation Preparation

• Assist in preparing validation protocols, data sheets, and execution checklists.
• Support dry runs, pilot builds, and equipment setup verification.
• Execute protocol steps under guidance and document results accurately.

4. Documentation & Records

• Prepare draft reports, summaries, and data packages for development activities.
• Maintain controlled records within the QMS.
• Ensure accurate, timely documentation aligned with regulatory expectations.

5. Shop-Floor & Cross-Functional Support

• Provide on-site support during development and pilot builds.
• Coordinate with manufacturing, engineering, and quality teams to resolve execution issues.
• Identify and escalate deviations, anomalies, or data integrity concerns promptly.

6. Continuous Learning & Support

• Learn and apply quality tools (FMEA, SPC, MSA, basic DOE concepts).
• Support corrective actions and process improvements identified during development.
• Follow guidance from the Senior Quality Engineer and contribute to team efficiency.

What We're Looking For

• Bachelor’s Degree in Engineering.
• 2 - 3 years of experience.
• Advanced computer skills including MS Office applications (Word/Excel/PowerPoint/Project/Visio) 
  Proficient in the use of Minitab statistical analysis.
• Experience with SolidWorks, ProE or Inventor, prototypes, 3D (desirable)
• Familiar with electronic management documentation.
• Spanish: Native Speaker, English: Fluent speaking, writing and reading.

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.

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