We are seeking an experienced Quality Validation Engineer to provide technical expertise and quality oversight for process validation activities within our internal teams and external partners, including CMOs and CTLs. This role is critical in ensuring compliance with GMP standards, FDA, and ICH guidelines , supporting qualification and validation efforts throughout all stages of biopharmaceutical manufacturing.

Qualifications & Requirements:

• Bachelor’s degree in Science, Engineering, or a related field.
• 8-12 years of experience in biopharmaceutical or pharmaceutical industries.
• Direct experience in process qualification and validation under FDA and ICH guidelines.
• Strong understanding of GMP compliance and validation principles in both U.S. and international markets.
• Experience working with CMOs and drug product manufacturing is preferred.
• Knowledge of biologics or gene therapy processes is a plus.
• Analytical method qualification and validation experience is advantageous.
• Ability to develop and implement innovative validation solutions to meet industry challenges.