As part of a the Accelerate Strategy, our client has launched a project which aims to design, build, commission and validate on its Braine l’Alleud site a new multi-product manufacturing facility to produce Mab-type bulk Drug Substances under cGMP conditions with high operational efficiency.
This new manufacturing plant will have to be integrated into the client's IT landscape/ecosystem considering digital transformation ambition, quality standards and operability.
--> On the application side a broad spectrum of functional domains (i.e. manufacturing, laboratories, qualities, facilities...) are impacted hence the scope is split into several streams (domains) each one being in charge a sub-set of specifics applications
--> On the infrastructure sites, all the back office / front offices capabilities are in scope like (non-exhaustive) hosting, connectivity (FO, cabling, WIFI, segmentation), computer room, hardware, …
--> IT is also accountable to ensure that all technologies (infrastructure, application as well as industrial asset or laboratory instrument) are implemented in a Trustworthy, Safe, Secure and compliant manner (TSSC) in line with the IT digital governance and standards defined as part of the IT TSSC Industrial FW.
--> IT is also in charge of delivering the workspace for the project team covering a full set of capabilities in terms of connectivity, devices (computer, printer) as well as a set of application collaborative environment, … that will be used by the project team.
--> Finally, an IT organizational transformation track will have to consider the change on the operating / support model that will be required to operate this new plant on 24/7 basis with high availability and quality standards
The mission is about leading and managing the overall IT Program
What you’ll do
- Being the IT partner for the Project, owning the overall IT Scope acting as IT lead within the project in charge of defining and delivering the End to End IT scope (technologies, infrastructure, application, project management practices) from the project set-up to change management and transformation needed to operate the new plan
- IT Program management orchestrating the delivery of End to End IT Scope managed through individual project on all aspects: governance, planning, resources, budget, delivery. Each sub-projects being managed by project managers (domain lead or dedicated project manager)
- The Project and IT Program governance ensuring engagement and alignment of all stakeholders including IT senior management up to ITLT around:
- Program set -up, organization, scope and planning
- Program performance & reporting (program / project dashboard, time adherence, budget, quality and compliance)
- Management of the escalation, risk & issue, scope change...
- Master’s degree (in Engineering, Computer Science, biosciences…)
- English, French
- Conceptual thinking, methodic and rigorous
- Be accountable and result oriented, striving for Operational Excellence and best practices
- Strong in change management, stakeholder engagement and communication skills
- Have an open, positive attitude, be a team player across different teams and different levels of the organization
- Be agile by being able to perform at operational and tactical, strategic level
- Ability to work creatively and analytically in a problem-solving environment
- Minimum 10 years’ experience and successful track records (at least 2 end to end delivery) in IT program management related IT integration of manufacturing green field facility in all its aspects: IT infrastructure, IT application and transformation with strong focus on manufacturing in pharmaceutical, regulated environment.
- Proven experience in significant major IT program management, including scoping, planning governance as well as relationships with business partners, external IT service partners / vendors
- Project / Program management methodologies certification
- Strong understanding of IT infrastructure and application landscape within pharma and biopharma industrial and security orientation
- Experiences in regulated process focused on manufacturing (GxP environment)
- Broad knowledge of IT infrastructure services used in pharmaceutical/manufacturing plant
- Broad knowledge of Engineering, automation practices and technologies and their integration and management as part of IT Landscape and standards
- Understanding of business and application technology capabilities
- SAP overall (SAP PP, QM, BM, WMS, PM, FI-CO…)
- Manufacturing & Quality: MES, EBR and integration with automation, LIMS