Description

You will own validation activities for vaccine and biologic manufacturing, ensuring process accuracy and regulatory conformity.

This role is on-site.

Responsibilities

• Write and execute protocols, reports, and procedures for adjuvant manufacturing and process validation runs.
• Document development studies and provide technical recommendations based on result interpretation.
• Translate processes to commercial operations by owning equipment unit operations and technology capabilities.
• Address non-conformance issues, change controls, deviations, and CAPAs to support strategic programs.
• Provide technical leadership and subject matter expertise during health authority inspections and investigations.

Required Skills

• 5+ years of experience in validation or manufacturing technology roles.
• Strong working knowledge of cGMP and regulatory guidance.
• Experience with Quality Control (QC) processes.
• Proven ability to act as a Subject Matter Expert (SME) in technical investigations.
• Competency in engineering fundamentals, including mixing, mass/heat transfer, and modeling.
• Experience with DOE studies and establishing scale-up/scale-down parameters.
• Ability to lead project teams and cross-functional task forces.

Preferred Skills

• Degree in any field (Any Graduate).

Key Skills

Education

Any Graduate