Senior Quality Engineer

A company is looking for a Senior Quality Engineer (Drug Product Development).

Key Responsibilities

Provide quality engineering expertise to various departments and ensure compliance with specifications and standards

Collaborate with internal stakeholders on validation and qualification activities, ensuring inspection readiness and regulatory compliance

Participate in risk analysis and continuous improvement initiatives related to quality processes and documentation

Required Qualifications

Bachelor of Science in a relevant field (Science / Engineering); relevant experience may substitute for education

3-7 years of cGMP experience, with a preference for Quality Engineering roles

Experience in the pharmaceutical industry and knowledge of cGMP regulations and FDA guidance

ASQ and / or ISO certification as a Certified Quality Engineer preferred

Experience in an ISO7 cleanroom environment and knowledge of aseptic techniques is advantageous