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Senior Engineer, Corporate Quality Assurance - Validation
QuVa - Advancing Healthcare Possibilities
Any Location, NJ
Category
Engineering
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Job Description
The Senior Engineer, Corporate Quality Assurance – Validation is responsible for ensuring company-wide validation and qualification activities comply with cGMP (21 CFR Parts 210/211), 21 CFR Part 11, and applicable USP and ICH guidelines. The role requires strong expertise in analytical validation and data integrity, with a focus on compliance, quality, and continuous improvement.
Requirements
Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related field (advanced degree preferred)
5–8+ years of experience in Quality Assurance, Validation, or related roles within the pharmaceutical or biotech industry
Working knowledge of USP and ICH regulatory requirements
Experience reviewing and approving validation documentation
Familiarity with GMP (Good Manufacturing Practices) environments
Benefits
Set, full-time, consistent work schedule
Comprehensive health and wellness benefits including medical, dental and vision
401k retirement program with company match
17 paid days off plus 8 paid holidays per year
Occasional weekend and overtime opportunities with advance notice
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