Join a groundbreaking initiative in the cell therapy industry, where your expertise will be pivotal to advancing innovative blood cancer treatments. The focus is on shaping the start-up of a new production site dedicated to CAR-T therapy, enhancing capabilities to make a difference in patients' lives.

As the ideal candidate, you are a driven Process Validation Engineer with a strong background in validation processes and team collaboration. If you're passionate about operating in a high-stakes environment and are ready to play a significant role in cutting-edge therapy development, this opportunity is for you.

• You define strategy, plan, and coordinate validation activities such as sterilization and hold time validation.
• You provide guidance on aspects of validations and qualifications throughout the process.
• You assure the revalidation of manufacturing and sterilization processes effectively.
• You write, review, and approve sterilization, APS, and other related validation plans, protocols, and reports.
• You participate in product transfer and system introduction teams to streamline processes.
• You engage in system and process improvement/optimization projects for enhanced efficiency.
• You review technical reports and information to ensure consistency with industry and regulatory standards.