Engineer

• Ownership for the development and execution of the Project Validation Master Plan (PVMP).
• Support the writing and approval of URSs (User Requirement Specifications) for facilities, equipment and systems.
• Lead the writing and execution of Impact Assessments for equipment and facilities, IQ & OQ, and Re-qualification, as well as PQ activities.
• Ensure flawless execution of Commissioning, Qualification, and Re-qualification works for manufacturing and laboratory equipment, execution systems, as well as facilities and utilities.
• Ensure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI’s and Company policies and corporate standards.
• Support investigations, deviations, corrective and preventive actions towards successful timely and compliant closure.
• Leading CQV role in compliance inspections / audits within area of responsibility.
• Provide leadership and act as expert in the field CQV.
• Develop & maintain in-depth understanding of the CAR-T manufacturing processes (including sound scientific understanding), operational procedures and manufacturing environment (Facilities, Utilities, Equipment, Systems, Processes).
• Conduct risk assessments and develop mitigation strategies to ensure compliance and safety in operations.

Senior Commissioning, Qualification, and Validation Engineer

Senior Commissioning, Qualification, Validation Engineer