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

This role supports the Quality department by providing sustaining quality engineering support for existing medical device manufacturing operations to maintain product conformity and adherence to the company’s Quality Management System.

What You'll Do

• Review packaging and labeling processes and identify validation gaps.
• Prepare and execute validation protocols, analyze results, resolve deviations, and complete reports.
• Coordinate readiness for the validation scheduled in December. This includes IQ, OQ and PQ.
• Update and provide guidance for packaging validation strategies.
• Execute packaging validation integrity testing (TMV) to challenge the process.
• Use statistical analysis to assess process validation.
• Update specifications, procedures, and work instructions.
• Train manufacturing and quality personnel on validated processes.

Deliverables:

• Validation readiness plan and report, completed validation documentation, updated procedures, and training records.

What We're Looking For

• Bachelor’s Degree in Engineering
• 8 years of experience
• Packaging & Labeling experience is desirable
• 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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