Validations Engineer II (Sterilization experience) #6677
ECI
Fecha: hace 3 semanas
ciudad: Alajuela, Alajuela
Tipo de contrato: Tiempo completo
Brief Description
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
The Engineer II will assist in the execution of sterilization validation protocols, the scope includes process validation, bioburden studies, biological indicator selection, and development of stability and shipping tests. The Engineer II will support Senior Engineers in ensuring compliance with sterilization standards and regulatory requirements while contributing to system implementation and documentation.
What You'll Do
Development and Execution of Validation Protocols:
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.
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
The Engineer II will assist in the execution of sterilization validation protocols, the scope includes process validation, bioburden studies, biological indicator selection, and development of stability and shipping tests. The Engineer II will support Senior Engineers in ensuring compliance with sterilization standards and regulatory requirements while contributing to system implementation and documentation.
What You'll Do
Development and Execution of Validation Protocols:
- Design of detailed protocols, including:
- Process design validation
- Installation qualification
- Operational qualification
- Performance qualification
- Update of operational procedures
- Determination of the final bioburden in locally produced units.
- Process mapping for process point of contamination.
- Biological Indicator (BI) selection:
- BI resistance
- BI population verification
- BI identification
- Preparation of detailed reports and a complete validation file that complies with ISO 13485 and local regulations.
- Bachelor’s Degree in Engineering
- 4 - 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
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.
Ver más empleos en Alajuela, Alajuela