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

BioProcess Specialist

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Engineering
Job ID:  67173

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?

To strengthen our Global Technical Engineering team, part of Global Engineering & Facilities department, we are looking for a talented individual to fill the position of Bio Process Specialist.

 

In this position, part of the Manufacturing Processes Center of Expertise, your mission will be leading the selection, design, procurement, construction, commissioning of our Bio Process Equipment and supporting qualification and validation activities. You will be part of the project team to deliver the best technical solution for our customers.

 

In a nutshell, the Bio Process Specialist:

  • Reports to the Discipline Lead – Process & Utilities
  • Deploys Technical Standards including Technical Safety and Green aspects
  • Is part of the project execution team, as from basic design
  • Is an active member of our Global Network of Experts (in & out UCB)

 

You like to work in an environment where you can:

  • Make sound decisions with agility
  • Be a key actor and participate in the transformation of our sites
  • Participate to the feasibility study and build the conceptual design for new projects incoming
  • Bring your technical expertise to ensure the best technical solution is provided to our customers
  • Ensure the technical follow-up of all projects managed by the Global Engineering

 

You will contribute by:

  • Acting as end-to-end responsible for “Bio Process” work package in engineering projects: from selection, design, procurement, construction to mechanical completion, commissioning to handover
  • Supporting qualification and validation activities
  • Working with our Execution Engineering Leads to implement the best solution to meet the customer needs
  • Defining the cost estimates for “Bio Process” related investments
  • Providing Engineering expertise to users
  • Providing expertise for obsolescence management
  • Participating to a professional network (internal and external to UCB) constantly assessing and seeking best practices for use at the site and for the broader UCB network
  • Bringing technical expertise during root-cause investigations (CAPA & Deviations)
  • Driving consistency with engineering standards and regulations
  • Ensuring the adherence to cGxP and EHS regulations and guidelines corresponding to related systems

 

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

 

Education

  • Master’s degree in Engineering (Dipl. Ing. / M. Sc.) or equivalent is required

 

Experience

  • 7+ years of relevant experience in projects of different scale and complexity in the pharmaceutical industry or equivalent
  • In-depth technical experience in a regulated environment with knowledge of biological engineering, pharmaceutical and/or chemical operations
  • Good understanding of the pharmaceutical industry not limited to technical aspects only
  • Good understanding of EHS (Environment, Health and Safety) and Quality aspects

 

Knowledge, Skills and Abilities

  • Strong knowledge of core principles in various engineering disciplines including manufacturing (e.g. cell culture, ATF, cell lisis, centrifugation/filtration, chromatography + UF/DF, formulation and aseptic filling, packaging, cGMP facility design) and support systems (e.g. WFI, PW, RO, clean steam, compressed gases, )
  • Experience with CIP/SIP and single use systems.
  • Good background in isolator technology
  • Experience with verification, qualification & validation (both V-cycle and ASTM E2500 approaches) is an asset
  • Ability to interpret and set-up P&ID (Piping & Instrumentation Diagrams) and PFD (Process Flow Diagrams) is required
  • Ability to lead & review PED (Pressure Equipment Directive) is an asset
  • Ability to act as technical process expert during HAZOP (Hazard and Operability study) / QRA (Quality Risk Analysis) / FMEA
  • Strong knowledge of cGMP/GLP regulations, USP, EP, JP, EMA, ICH, FDA CMC, ISPE and PDA Guidance Documents is preferred.
  • Recognized as an expert or leader in their specific field.
  • Experience in Engineering Technologies supporting product development and/or manufacturing (both highly preferred)
  • Knowledge of Bio Safety Levels requirements (up to BSL2) and its impact on own discipline
  • An ability to take initiative and work both independently and in a team environment 
  • Dynamic person with strong value commitment   
  • Experience in large and complex projects as well as both formal and informal leadership / coordination
  • Experience with EPC (Engineering, Procurement and Construction) and EPCM (Engineering, Procurement and Construction Management) contracting models is an asset
  • Manages with a matrix of reporting lines and across functional areas
  • Ability to share good practices and knowledge
  • Can identify latest trends in the industry and can think out of the box
  • Can benchmark against peers in the industry
  • Excellent communication skills (able to present to Management) and ability to prioritize multiple tasks and to work on multiple projects simultaneously.
  • Broad Leadership experience for the management of internal and external resources in international environment
  • Strong technical skills and the ability to explain complex issues and requirements in an easily understood manner.
  • Ability to apply previous learning and ideas to new situations, projects and teams, developing creative solutions to manage risk to a reasonably practicable level.
  • Strong technical, interpersonal and leadership skills.
  • Ability to communicate effectively and make presentations with audiences that include but are not limited to management, coworkers, clients, vendors, contractors, and other stakeholders
  • Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment. Able to both take direction and mentor other team members
  • Able to translate customers’ needs in technical requirements
  • Demonstrated verbal and written communication skills and the ability to compose correspondence and reports
  • Full professional proficiency in French and English (both oral and written)
  • Willing to travel up to 10% (mainly across Europe)

 

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. 

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