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
Support the Quality Engineering Team with Manufacturing Process controls remediation activities. The service will be provided through different roles.
What You'll Do
- Execute a retrospective analysis of activities performed in the past: CAPAs, NCEs, Dispositions, Change Records, etc.
- Lead all remediation tasks as dictated by the Remediation Project Managers, including:
- QMS Procedures updates.
- Development of new fixtures, equipment and/or Poka Joke process.
- Execution of Process Characterization (DOEs)
- Develop and execute IQ, SW, OQ and PQ validations protocols and reports
- Support CAPA and NCE documentation to ensure the completeness of activities, adherence to good documentation practices, and compliance with regulatory standards.
- Support in the writing of the CAPA Investigation report applying technical writing skills and ensuring compliance with good documentation practices and regulatory standards.
- Ensure clear traceability between problem statement, root cause, corrective/preventive actions and effectiveness check plan.
- Implement remediation execution to ensure commitments are met and risks are mitigated in a timely manner.
- Create KPI metrics to measure the effectiveness of the site CAPAs, providing detailed trend analysis and performance reports to senior leadership.
What We're Looking For
- Bachelor’s Degree in Engineering.
- 8 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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