Validation Engineer/Specialist
Validation Engineer/Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
DESCRIPTION
The Validation Engineer/Specialist will provide support to the engineering and quality department in the validation of products equipment or process in the Manufacturing and Packaging areas.
Also support pro-field executions and must have availability to work in different successful candidate must have Validation Experience in regulated environment industries such as pharmaceutical bio-pharmaceutical or medical devices companies.
Generates executes reviews and complete qualification and validation documentation summary reports and associated data for conformance to regulations SOPs specifications and other applicable acceptance criteria.
EDUCATION
Bachelor Degree in Engineering or Science and 5-10 years of experience.
REQUIREMENTS
- A solid understanding of FDA Validation guidelines
- GMP and regulatory experience with expertise in process validations.
- Experience in writing and executing validation protocols (i.e. DQ IQ OQ PQ).
- Experience in writing SOPs
- Experience with Technical Writing preferred.
- Statistical knowledge DOE and Quality Process Control experience is preferred.
- Project Management knowledge.
- Fully Bilingual (English/Spanish)
Ultimate Solutions Corp is an equal opportunity employer.
Required Experience:
Unclear Seniority
Employment Type
Full Time
