Quality Engineer

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