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Job Description

About the Role:

Takeda is seeking a highly skilled and experienced Senior Cleaning Validation Engineer to join our Purification, Filling, and Cleaning Validation team. This role is crucial in managing resources, leading the cleaning validation program, coordinating validation activities and ensuring the compliance and effectiveness of cleaning processes throughout their lifecycle. As a key player, you will contribute to continuous improvement and participate in audits, supporting the Validation Leader as an experienced cleaning validation expert and delegate.

How you will contribute:

• Manage the Cleaning Validation Program across all phases of the Cleaning Validation Lifecycle: Stage 1, Stage 2, and Stage 3.
• Prepare, implement, and execute validation documentation to ensure compliance with Takeda’s procedures and regulations.
• Oversee contractors and engineers, offering day-to-day guidance and support for Cleaning Validation activities.
• Act as a validation representative for projects, defining Cleaning Validation activities, and developing comprehensive Validation Plans and methodologies.
• Review, approve, and prepare Cleaning Validation protocols and reports to maintain validated status.
• Coordinate and manage incidents with appropriate documentation, corrective actions, and follow-ups.
• Organize and coordinate PQ Cleaning Validation activities with various departments, including on-the-ground support as needed.
• Analyze, interpret, document, and report testing results, ensuring reliability and compliance.
• Update Cleaning Validation procedures documentation, acceptance limits calculations, and CVMP as needed.
• Ensure effective, compliant Cleaning Validation practices throughout the lifecycle of the cleaning process.
• Perform periodic reviews of control limits for rinse samples (e.g., TOC, online conductivity), ensuring Stage 3 compliance.
• Defend Cleaning Validation processes during regulatory inspections and prepare validation-related documentation for submission files.
• Contribute to continuous improvement initiatives and international standardization efforts, ensuring alignment with best practices.
• Provide training, share knowledge across global Takeda sites, and participate in quality-related issues, including GMP compliance and system optimization.

What you bring to Takeda:

• BS Degree or equivalent in Chemistry, Life Science, or related discipline.
• Minimum of 3 years experience as a Cleaning Validation Engineer.
• Project and people management experience.
• Ability to work cross-functionally and lead validation projects.
• Excellent communication skills, fluent in English (written and spoken).
• Familiarity with Quality Management and GxP Regulations.
• Ability to prioritize multiple tasks and work on multiple projects simultaneously.
• Knowledge of Validation Methodologies, Quality Systems, European and FDA regulations, cGMP, GDP.
• Strong analytical skills with systematic approaches to problem-solving.
• Ability to lead and coach the cleaning validation team.
• Ability to influence stakeholders and propose solutions.
• Collaborative and proactive team member.
• Innovative thinker with the ability to propose long-term plans.

What Takeda can offer you:

We want our employees to succeed in everything they do – at work, at home, and in the community. This is why we offer world-class benefits and access to resources that can support people.

Our sector and the needs of our patients are constantly changing, which is why we emphasize continuous training. We actively support and invest in the development of our employees through a 50/40/10 training model.

We offer a comprehensive benefits package, prioritizing wellbeing, career growth, and work-life balance:

• Generous Time Off: 20 days of paid vacation in accordance with Belgian legislation and 12 Working Time Recovery days with additional days granted based on seniority and age.
• Health & Wellbeing: Comprehensive health and hospitalization insurance, annual check-ups starting at age 45, and support for preventive healthcare.
• Family Support: Paid leave for maternity, paternity, and adoption, along with dedicated spaces for nursing mothers.
• Career Development: Access to a Learning Catalog, language courses, and opportunities for internal and international mobility.
• Transportation & Eco-Benefits: Contributions for public transport, incentives for cycling, and on-site charging stations for electric vehicles.
• Additional Perks: Meal vouchers, eco-cheques, a flex plan, a 13th-month salary, and pension support.

Important Considerations:

At Takeda, our patients rely on us to create quality products, and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• Work in a cold, hot environment and load manual handling.

• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

• Work around chemicals and biologicals products that may require specific protection (respiratory, skin, etc.).

More About Us:

The Takeda Lessines manufacturing site plays a vital role in the production of Takeda’s plasma-based therapies. With over 75 years of pioneering legacy, Takeda is a global leader in rare diseases and ranks in the top three for plasma-derived products. Our Lessines manufacturing site is a state-of-the-art biotechnology production facility with over 50 years of experience, specializing in immunoglobulin purification, plasma-derived therapies, and packaging for treatments targeting blood disorders. Serving more than 250,000 patients worldwide, we are dedicated to delivering high-quality therapies that make a significant impact. As Takeda's third-largest global production site, Lessines plays a pivotal role in our international operations, producing and distributing million vials annually to more than 80 countries.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

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Locations

BEL - Lessines

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time