Senior Engineer, Corporate Quality Assurance - Validation

QuVa - Advancing Healthcare Possibilities
Any Location, NJ
Category Engineering
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
]]>