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Let's push the boundaries together and make the most of your talents!

Qualification Engineer

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  70267

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?

 

We recently announced the construction of an innovative and environmentally sustainable multi-product biological manufacturing facility on our site in Braine l’Alleud. This new biotechnology plant is being constructed to accompany the company’s growth strategy and to prepare for the launch and for the long-term supply of future medicines that are currently in clinical development. This aims to contribute directly to drive our global ambition of improving the life of patients suffering from rare diseases.

 

The new facility, representing an investment of more than 300 million euros over the coming years, is expected to be operational in 2024. The biotechnology plant will be one of the largest and most modern in Belgium. 

 

We are now looking for talented, inspired, daring and engaged individuals who share our ambition to create value for patients and who want to be part of our journey to prepare for the next biopharmaceutical product launches. 

 

In this context, we want to strengthen the team in charge of the project deployment and to start-up these future manufacturing activities: we are looking for a Qualification Engineer.

As a Qualification Engineer you will identify and foster purposeful partnerships with key scientific influencers to drive new sources of patient value.

You like to work in an environment where you can:

  • Supervise and coordinate commissioning and verification activities to demonstrate that systems are installed safely and perform according to specifications.
  • Ensure that commissioning and verification activities are planned according to project schedule.
  • Ensure that any significant risk (planning, cost, quality, safety, etc.) is appropriately mitigated during design phase, before to start commissioning activities and during testing activities and / or escalated to management.
  • Collaborate with business and quality partners to;
    • understand stakeholders needs.
    • make sure stakeholders understand C&V needs.

 

You will contribute by:

  • Reviewing and approving technical specifications (URS) and quality risk assessment.
  • Ensuring design verification is performed appropriately to demonstrate requirements are embedded in the design of system.
  • Writing and approving design verification reports.
  • Leading design verification activities.
  • Writing / reviewing and approving test plans and related protocols (FAT, SAT, etc.) to ensure documented evidence to requirements.
  • Writing / reviewing and approving reports related to test protocols. Ensuring punch list / defects are appropriately managed.
  • Ensuring walkdown of mechanically complete systems and commissioning / verification activities are performed appropriately.
  • Leading commissioning / verification and testing activities.
  • Writing and approving release reports for GMP use of systems.
  • Ensuring system C&V activities meet C&V global schedule.
  • Participating in the implementation of QALM (eVerification tool).
  • Participating in reviewing / writing project C&V procedures, master plan and plans.
  • Being agile to support C&V team based on project priorities.
  • Supporting troubleshooting and resolution of any issue.
  • Managing technical discussion on all deviations, changes, design issues and test failures by involving appropriate SMEs.
  • Escalating to management any issues that cannot be solved by the team.
  • Ensuring that decisions are based on scientific evidence / rationale and that level of documentation is commensurate to the level of risk.
  • Ensuring document are controlled, executed and filled in to a high standard.
  • Ensuring project procedures are understood and applied.
  • Promoting continuous improvement within the C&V team and the project team by escalating any pertinent observation.
  • Liaising with quality partners.
  • Ensuring all safety measures have been appropriately implemented prior any C&V activities.
  • Making sure all tests are well planned and supervised by appropriately trained, inducted and technically competent staff.
  • Ensuring that project procedures are understood and applied.
  • Liaising with safety partners.
  • Organizing equipment / system training prior to handover with support of vendors.

 

 

Interested? For this position you’ll need the following education, experience and skills:

 

  • Master’s Degree
  • Demonstrated experience in similar biotech project (including LOTO, Commissioning, Verification, etc.)
  • Very good knowledge of GMP and HSE standards
  • Technical expert in biotech equipment / systems
  • Technical expertise in biotech equipment or systems related to their package (minimum 5 years’ experience in engineering or manufacturing environment)
  • Ability to work in highly dynamic environment and to handle challenging situations
  • High communication skills (leadership, negotiation, change management, facilitation)
  • Decision making ability and high sense of responsibility
  • Ability to challenge and argument
  • Ready to travel a limited period of time
  • Fluent in French & English

 

 

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

 

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

 

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 

Apply now »