Description

You will support manufacturing processes and techniques to ensure the accuracy and conformity of vaccine and biologic production.

Responsibilities

• Write protocols, reports, procedures, and memos to support adjuvant manufacturing, engineering investigations, and process validation runs.
• Execute and document development and validation studies, providing technical recommendations based on interpreted results.
• Own equipment unit operations and technology capabilities, translating processes to commercial operations.
• Support strategic programs by addressing non-conformance issues related to change controls, deviations, and CAPAs.
• 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