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Job Description

About the Role:

The Filling Engineer is integrated in theEngineering structure.
The filling area is composed of 2 filling lines and their setup area. The lines are composed of machine such as Filling machine, sterilizer, CIP/SIP, FMS. You will lead the technical execution of critical/complex projects according to the Site Capital roadmap

How you will contribute:

• Participate on request of Manufacturing, Reliability, Maintenance. Quality, Validation, Automation as SME/System owner during investigations
• Continuously improve process and equipment
• Design, installation/modification, commissioning and qualification of systems according to EHS, GMP (Good Manufacturing Practices) and GEP (Good Engineering Practices) requirements
• Act as single point of contact for the suppliers during the project lifecycle.
• Execution of IQ and OQ on site.
• Technical support for Manufacturing during the execution of the PQ.
• Support for project spending forecast.
• Training of users impacted by changes and new equipment.
• Manage that the technical documentation under his (or her) responsibility (Protocols / Drawings / technical data sheets…) is up to date and available for each employee of TAKEDA Lessines.
• Define and write the user requirements and functional specifications (URS/FDS) of new or modified systems in collaboration with the other departments.
• Participate to the Projects Core Team as technical expert
• Execution of FAT at suppliers
• Be able to lead or coordinate the day to day work of a limited amount of contractors/external resources.
• Be on the floor to understand and analyze problematic.
• Recommend efficient improvement to minimize production down time and increase quality.
• Support site activities as a technical professional to facilitate process deviations.
• Assure strict compliance with cGMP, 21 CFRs, Corporate, Divisional and regulatory requirements
• Provide knowledge support to contractors for equipment issues.

What you bring to Takeda:

•  Master degree in Mechanics, Electrics, Electro-mechanics, Bio-engineering: (Or Bachelor degree+ Exp.)
• Engineer with at least 10 years of work experience.
• Comfortable with the technology evolution for electrics and mechanical systems.
• Fluent in French and English, any additional language is an asset
• Able to understand technical installations, equipment and systems used on the site.
• Comfortable with technical & quality documentation according to GxP.  Able to be a technical leader inside project development, investigations  problematics. 
• Must be aware of the latest technology available and innovations to implement state of the art solutions on site. 
• Ability to lead and perform effectively in multi-disciplinary teams
• Must have the ability to effectively participate to Engineering projects, coordinate suppliers, and drive results. 
• Develop understanding of business drivers and customer needs.
• Must be comfortable with MS OFFICE (Especially Word, PowerPoint, Excel;).
• Experience with Quality Systems and Processes in a GMP regulated and FDA licensed manufacturing site. 
• Must have good experience in project management, preparing project budgets and timelines
• Experience in managing of contractors
• Demonstrated track records of Project execution involving Filling Line Equipment 

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, jewellery, 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:

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.

The Takeda Lessines site is a state-of-the-art plasma manufacturing plant with over 50 years of experience, specializing in immunoglobulin (IG) used for plasma-derived therapies to treat rare and complex chronic diseases. As Takeda's third-largest global production site, Lessines plays a pivotal role in our international operations, proudly producing and distributing over a million vials annually to more than 80 countries.

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

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