Are you an experienced professional in the biotech/biopharma industry with expertise in sterilization and decontamination processes?
Do you want to play a key role in ensuring process robustness and compliance in a cutting-edge CAR-T manufacturing environment?
Then this position as Senior Process Engineer - Sterilization is for you!
What can you expect?
As a Senior Process Engineer - Sterilization, you will be part of the Manufacturing Science and Technology (MSAT) team, responsible for developing and executing sterilization and decontamination cycles (autoclaves and VHP) and ensuring their validation and implementation.
You will lead technical investigations, drive process improvements, and collaborate closely with cross-functional teams to enhance manufacturing efficiency and compliance.
Legend Biotech is a global biotechnology company dedicated to developing, manufacturing, and commercializing innovative and life-saving cell therapies for the treatment of chronic and life-threatening diseases, such as cancer.
Legend Biotech focuses on the production of advanced CAR-T cell therapies for the treatment of multiple myeloma, in close collaboration with Johnson & Johnson.
Your new role
Are you an experienced professional in the biotech/biopharma industry with expertise in sterilization and decontamination processes?
Do you want to play a key role in ensuring process robustness and compliance in a cutting-edge CAR-T manufacturing environment?
Then this position as Senior Process Engineer - Sterilization is for you!
What can you expect?
As a Senior Process Engineer - Sterilization, you will be part of the Manufacturing Science and Technology (MSAT) team, responsible for developing and executing sterilization and decontamination cycles (autoclaves and VHP) and ensuring their validation and implementation.
You will lead technical investigations, drive process improvements, and collaborate closely with cross-functional teams to enhance manufacturing efficiency and compliance.
Your Responsibilities
* Develop and execute sterilization and decontamination cycle validation strategies in alignment with product requirements.
* Lead/support the design of business cases, study designs, and project implementations.
* Act as a Subject Matter Expert (SME) for sterilization and decontamination processes.
* Ensure seamless knowledge transfer across functions within MSAT and other relevant teams.
* Perform data trend analysis and evaluate process performance, including validation study assessments.
* Provide scientific and cGMP expertise to support process lifecycle activities and ensure compliance with regulatory requirements.
* Lead and support large-scale projects focused on process optimization and operational excellence.
* Participate in regulatory inspections and contribute to compliance-related documentation such as Change Controls, CAPAs, and risk assessments.
Experience:
* 5-10 years of relevant experience in a cGMP environment within the pharmaceutical industry.
* Strong background in sterilization/decontamination validation and manufacturing support.
Languages:
* Fluent in English (knowledge of Dutch is a plus).
Strengths:
* Ability to work independently with minimal guidance.
* Strong organizational skills, capable of managing multiple priorities in a fast-paced environment.
* Excellent communication and presentation skills.
* Ability to synthesize complex technical issues and communicate effectively at all organizational levels.
* Strong problem-solving, analytical, and critical-thinking skills.
* Team-oriented mindset with the ability to build strong cross-functional partnerships.
* A results-driven approach with a commitment to continuous improvement.
Expertise:
* In-depth knowledge of cGMP regulations related to sterilization and decontamination processes.
* Experience in conducting root cause analysis and implementing corrective and preventive actions.
* Strong statistical analysis skills for data-driven decision-making.
* Familiarity with regulatory submission processes and requirements for manufacturing validation.
* A meaningful job with an excellent work-life balance.
* A supportive and innovative work environment.
We value and encourage learning and personal development.
* The opportunity to work with people from all over the world.
* A contract of indefinite duration and an attractive salary package complemented by many fringe benefits, such as additional statutory vacations, meal vouchers, group and hospitalization insurance, double vacation pay, an end-of-year and performance bonus
* Many fun and informal events.