Quality Operations Equipment and Critical Utilities Specialist

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Job Description
About the Role:
As a Quality Operations Equipment and Critical Utilities Specialist, you will play a key role in ensuring compliance, supporting manufacturing processes, and driving quality excellence. Your expertise in areas such as equipment, building systems, HVAC, and critical utilities (e.g., pure steam, softened water, DIW, WFI) will be central to maintaining operational reliability. Reporting to the Quality Ops System and Purification Manager, you will support quality systems deployment and contribute to impactful decisions that align with Takeda's mission.
How You Will Contribute:

• Approve risk assessments and restart requirements following shutdowns or slowdowns.
• Investigate, evaluate, and approve Deviation/EUME reports while ensuring timely closure.
• Lead or support ownership of deviations, CAPAs, and document change requests in your area of expertise.
• Represent the quality function during approvals and closures of change controls in utilities, equipment, and facilities.
• Review, approve, and oversee maintenance corrective interventions and work orders (WOs).
• Collaborate with manufacturing teams to ensure compliant decision-making on the floor.
• Conduct GMP Gemba reviews to assess operations for consistency, reliability, and adherence to cGxPs.
• Support external audits and the organization of reprocessing activities.
• Drive continuous improvement initiatives, such as Yellow Belt and DMAIC projects.
• Participate in risk assessments (e.g., FMEA) and support quality systems deployment activities.

What You Bring to Takeda:

• A Master's degree in biological, chemical, or biochemical sciences (or an equivalent qualification with relevant experience).
• 3-5 years of experience in GMP environments with knowledge of quality systems.
• A working knowledge of risk-based approaches in deviation and change control management.
• Proficiency in reading and writing English.

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