Quality Engineer

Job Summary

A company is looking for a Senior Quality Engineer to oversee drug product validation and qualifications.

Key Responsibilities

• Provide quality engineering expertise to various departments, ensuring compliance with specifications and standards
• Collaborate on validation packages and deliverables, including risk assessments and protocols
• Maintain inspection readiness and compliance with regulatory requirements and internal policies

Required Qualifications

• Bachelor of Science in a relevant field (Science/Engineering) or equivalent experience
• 3 - 7 years of cGMP experience, preferably in Quality Engineering roles
• Experience in the pharmaceutical industry, with knowledge of cGMP regulations and FDA guidance
• ASQ or ISO certification as a Certified Quality Engineer is preferred
• Experience in an ISO7 cleanroom environment and knowledge of aseptic techniques is a plus