Quality Validation Engineer
About The Position
The vendor/client is seeking a Quality Validation Engineer with 6+ years of experience in pharmaceutical or biopharmaceutical manufacturing industries. The candidate must have a strong background in Quality Validation, Quality Systems, and Regulatory Compliance. The position requires experience supporting validation activities across equipment, process, facility, and computerized systems, as well as documentation review. The candidate should also have strong experience with quality and regulatory requirements, including CAPA, QSR, FDA, GMP, Quality Systems, and Regulatory Compliance. The candidate should have experience working within pharmaceutical or biopharmaceutical manufacturing environments, rather than purely laboratory, research, or non-manufacturing environments.
Requirements
- Bachelor's degree in Electrical Engineering or related Engineering field
- 6+ years of experience in pharmaceutical or biopharmaceutical manufacturing environments
- 7 years of experience (as specified in must-have requirement)
- Strong background in quality validation, quality systems, and regulatory compliance
- Expertise with CAPA, QSR, FDA, GMP
- Experience supporting validation activities, including equipment, process, facility, computerized systems, and documentation review.
- Strong Quality Systems experience
- Experience with Quality Systems, Quality documentation, Documentation review, Regulatory compliance, GMP compliance, FDA requirements, QSR requirements
- Experience with FDA, GMP, QSR, Regulatory Compliance, Quality Systems, Quality Validation
- Understanding of how validation activities are performed and documented within a regulated manufacturing environment.
Nice To Haves
- Master's degree preferred
Responsibilities
- Supporting validation activities, including equipment, process, facility, computerized systems, and documentation review.
- Equipment qualification/validation
- Supporting equipment validation activities
- Validation documentation and review
- Process validation activities
- Manufacturing process validation
- Supporting validation execution and documentation
- Facility validation
- Manufacturing facility-related qualification/validation activities
- Computerized systems validation
- Validation documentation
- Quality review of computerized systems validation activities
- Review of validation documentation
- Quality documentation review
- Ensuring documentation meets applicable GMP and regulatory requirements
- Working within a regulated pharmaceutical/biopharmaceutical manufacturing quality environment.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
