Biopharma Validation Engineer

Seeking a Lead Engineer, Quality Validation to oversee process validation, technology transfers, and compliance in biopharmaceutical manufacturing. This role ensures GMP, FDA, and ICH compliance while managing validation activities with internal teams and CMOs.

Key Responsibilities:

Oversee process validation, qualification, and technology transfers

Ensure compliance with GMP, FDA, and ICH guidelines

Conduct risk management, deviations, and process verification

Collaborate with CMOs and cross-functional teams

Provide updates and reports to senior management

Qualifications:

8 12 years of experience in biopharma/pharma validation

Strong knowledge of GMP, process validation, and regulatory standards

Experience with CMOs, process transfers, and analytical validation

Excellent problem-solving, communication, and leadership skills