Job Description

This position supports manufacturing excellence, ensuring the accuracy, conformity, and competitiveness of processes and techniques used in vaccine and biologic production at industrial sites.

The mission is to deliver robust and efficient process testing with associated know-how transfer to Manufacturing & Quality Control (QC).

Key Responsibilities:

• Develop protocols, reports, procedures, and memos to support adjuvant manufacturing activities, including engineering, investigational, definition, development, and process validation runs.
• Support execution of development and validation studies.
• Document and interpret study results, providing recommendations.
• Provide technical leadership as a subject matter expert in multiple areas of responsibility.
• Develop and execute training programs for relevant audiences.
• Ensure compliance with cGMP and other internal and external quality and regulatory guidelines, as well as health and safety standards.
• Lead project teams and provide leadership within area of expertise.
• Assess existing processes and workflows, translating them to commercial operations.
• Owning equipment unit operations and technology capabilities.
• Communicate findings and proposals to upper management.
• Improve Manufacturing Technology strategic programs by addressing non-conformance issues related to change controls, deviations, corrective and preventative actions (CAPAs).
• Participate in Gemba/shop floor walks to learn about production processes and interview stakeholders to collect data for continuous improvement of strategic programs and development of validation strategies/documents.
• Develop and update standard operating procedures and related technical documents to align with program strategies under a cGMP environment.

Requirements:

• Bachelor's or Master's degree in basic sciences, math, engineering, or pharmacy, with 2 years' experience, or PhD with experience in biological processes or analytics in a cGMP environment.
• Proficiency in structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, and Process Control Strategies.
• Validation and Quality background required, including both.
• Sterilization validation and equipment validation experience beneficial.
• Might be final approver for documents.
• Reviewing and approving validation/qualification type documents highly valued.
• Detailed orientation and strong working knowledge of Quality System Regulations.
• Experience leading CAPA activities.
• Excellent written and oral communication skills.
• Ability to work in cross-functional teams, provide analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.

Preferred Experience:

• Equipment start-up, qualification, and validation experience.
• Prior experience preparing and executing process performance qualification documents (PPQ).