Title: Quality Assurance Validation Engineer – Princeton, NJ

Location : Princeton, NJ (Onsite)

We are seeking a Quality Assurance Validation Engineer with 5+ years of experience in the pharmaceutical or biotechnology industry. The ideal candidate will be responsible for ensuring that validation activities comply with industry regulations and standards and supporting quality assurance efforts across the organization.

Key Responsibilities :

• Develop and execute validation protocols (IQ, OQ, PQ) for systems and equipment.
• Ensure compliance with FDA 21 CFR Part 211 , cGMP , and other regulatory requirements.
• Review and approve validation documentation (protocols, reports, SOPs).
• Perform risk assessments and support CAPA (Corrective and Preventive Actions).
• Collaborate with engineering , quality control , and manufacturing teams to support validation processes.
• Support regulatory inspections and audits by providing validation documentation.

Requirements :

• 5+ years of experience in Quality Assurance and validation within the pharmaceutical or biotechnology industries.
• Strong knowledge of cGMP , FDA regulations , and validation processes .
• Experience with equipment and process validation , change control , and risk management .