CAR-T MSAT Senior Process Engineer - Sterilization

Job Description

Legend Biotech is seeking a Senior Process Engineer - Sterilization to join their Manufacturing Science and Technology (MSAT) team in Ghent, Belgium. The role involves developing and executing sterilization and decontamination cycles, ensuring their validation and implementation in a CAR-T manufacturing setting. The Senior Process Engineer will lead technical investigations, drive process improvements, and collaborate with cross-functional teams to enhance manufacturing efficiency and compliance.

Responsibilities include:

• Developing and executing sterilization and decontamination cycle validation strategies.
• Leading the design of business cases, study designs, and project implementations.
• Acting as a Subject Matter Expert (SME) for sterilization and decontamination processes.
• Performing data trend analysis and evaluating process performance.
• Supporting process lifecycle activities and ensuring compliance with regulatory requirements.
• Leading and supporting large-scale projects focused on process optimization.
• Participating in regulatory inspections and contributing to compliance-related documentation.

The ideal candidate will possess:

• A minimum of a Master’s degree in Engineering, Science, Pharmacy, or a related field.
• 5-10 years of relevant experience in a cGMP environment within the pharmaceutical industry.
• Strong background in sterilization/decontamination validation and manufacturing support.
• Fluency in English (knowledge of Dutch is a plus).
• Strong organizational, communication, and problem-solving skills.

Legend Biotech offers:

• An excellent work-life balance
• Supportive and innovative work environment
• Learning and personal development opportunities
• A contract of indefinite duration
• Attractive salary package and fringe benefits
• Fun and informal events