Process SME

Braine-l'Alleud, Walloon Region, BE

Company: UCB

Category: Computer and Mathematical Occupations

Published on 2021-12-12T11:14:45.000000Z

Make your mark for patients.

We’re here because we want to build the future and transform patients’ lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?

At UCB, 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. Construction and equipment installment is well on its way for starting up in the first quarter of 2022. 

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.

To strength the team currently in charge of the project deployment going from design to execution and testing, we are looking for a Process SME to assist in the commissioning and start up activities.

As a Process SME you like to work in an environment where you can: 

Write, review, approve the technical documentation required to support the project. Actively participate in supplier monitoring (technical, planning, change management). Make sure that all interfaces within their packages / process modules are correctly defined.

You will contribute by:

Actively participating in the definition and execution of technical activities by equipment suppliers. Controlling the progress of these activities in connection with the defined schedule. Actively participating in the definition and the setting up of the requirements to start manufacturing operations of the new facility.  Identifying the risks during the execution of the package (HSE, quality, cost, timing, ...), estimating their impacts and report them to the Process Lead. Actively participating in the definition and implementation of interfaces with the Engineering Company so that equipment can be integrated effectively and efficiently. Coordinating effectively and efficiently between the different functions of the project and their SMEs (Clean Utilities, Infrastructure, C&V, Automation, etc.) and the Engineering Company. Checking that the Minutes Of Meeting are complete (decisions and actions). Following up on actions according to the set deadlines. Writing, reviewing and approving the technical documents required by each phase of the project, applying GEP, GMP,… standards. Ensuring that Process equipment is developed in a harmonized manner, according to industrial technical standards and GEP / GMP rules. Implementing the defined C&V strategy. Establishing and / or reviewing the required documentation for FAT / SAT / Commissioning / Verification. Participating in the preparation and planning of each stage of the project (Design, Purchase, FAT, MC, SAT and HO). Carrying out the activities required during these different phases. Participating in the integration of newcomers to the project by coaching them as needed.

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

Master's degree Minimum 3 years of experience in biotech production, in a GMP environment Operational experience in biotech production equipment for monoclonal antibody purification processes Experience in C&V with application of the ASTM E2500 standard Good knowledge of automated systems Strong knowledge of GMP and regulations Demonstrate a very good team spirit Capacity to be autonomous and pro-active Ability to positively challenge and argue Decision-making and responsibility at his level Fluent in in English and preferably French (or willing to learn)

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.

Click here if you are curious to know more about a what you can expect from a career at our state-of-the-art Campus in Braine l'Alleud.

Apply for the job