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Automation/process Sme

il y a 1 mois

Brainel'Alleud, Belgique UCB S.A. Temps plein

**Make your mark for patients**

**At UCB, we put our hearts, minds and skills into making a difference for people living with severe disease. Working together to push the boundaries, we combine the best of our talents to unleash innovation. Would you like to join us on our pioneering journey?**

**UCB, a global biopharmaceutical company, recently announced the construction of an innovative and environmentally friendly multi-product biomanufacturing facility at its Braine l'Alleud Campus. The new biotech plant is being built to support the company's growth strategy and prepare for the launch and long-term supply of future drugs in clinical development. This is intended to contribute directly to driving our global ambition to improve the lives of patients suffering from rare diseases.**

**The new facility, representing an investment of more than EUR 300 million, is expected to be operational in 2024. The biotech facility will be one of the largest and most modern in Belgium.**

**We are now looking for talented, inspired, bold and committed people who share our ambition to create value for patients and who want to be part of our journey to prepare for future biopharmaceutical product launches.**

To strengthen our **Manufacturing Engineering & HS&E** team, we are looking for a talented individual to fill the position of **Automation/Process SME, **based in Braine-l’Alleud, Belgium.

As part of InfleXio core team (build a new biological mammalian facilities), the Automation/process SME will report to the InfleXio Automation Lead with dotted line to InfleXio Process Engineering Lead.

As Automation/process Subject Matter Expert, she/he will ensure good engineering practices and ensure design put in place for InfleXio project meets UCB expectations and strategy for all assigned packages

**The Automation/process SME will**:

- Ensure for its Packages that deliverables will be provided timely and aligned with project planning with the right expected quality and according to the allocated budget
- Report the progress for its Packages
- Be accountable for its Packages and in strong collaboration with Automation Integrator company
- Align design expectations with the other project disciplines: Process, automation, QA, C&V, E&I, etc
- Anticipate, manage and report risks from Detail Design till validation batches
- Ensure efficient handover to operation teams and ensure they will be trained to operate the automated installation
- Align and translate process strategies (production cleaning, sterilization) between process equipment and automation systems
- After handover be part of the automation Engineering local team and make the bridge with process Engineering team
- During plant operation ensure plant support in term of automation and troubleshooting

**Main accountabilities**
- Verify project documentation coming from Engineering Company and Automation Integrator
- Align CIP/SIP strategy between process, C&V and automation team
- Challenge process design to ensure alignment between equipment and its ways they are controlled by automation systems
- Attend to workshops to ensure alignment with the different companies and disciplines
- Participate to the overall automation strategy for InfleXio (Library, Recipe structure, HMI philosophy, reporting, alarm strategy, etc.)
- Follow ‘up Automation Integrator and Vendor Packages during development and execution
- Verify each sub-contractor scope of work and report misalignment
- Verify Engineering Company deliverables and anticipate any cost increase
- Attend to FAT / SAT / commissioning / Validation
- Ensure EC and subcontractor follow GMP and HSE regulations
- Proactively report and manage risks
- Review verification protocols
- Organize operator training
- Perform handover to operation and support team
- Manage punch list related to its packages
- Translate process improvement/ modifications into automation requirement
- Support and troubleshoot installations to guarantee process Drug Substance manufacturing

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

- Master’s degree
- At least 5 years’ experience in Bio-Process and/or Automation
- Proven involvement in significant major engineering projects, including risk/mitigation management

**Competencies**:

- Goof level of French and English
- Strong knowledge of cGMP
- Strong knowledge in design, execution and C&V
- Ability to translate and present expert concerns to facilitate decision
- Ability to work in highly dynamic environment and to handle challenging situations
- High communication skills (leadership, negotiation, change management, facilitation)
- Able to reach team decision and high sense of responsibility
- Ability to challenge and argument

**We can offer** you an informal and open working environment that does not lock scientists into structure and hierarchy. Freedom to take space to pursue your own ideas and

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