freelance
Inflexio IT TSSC Industrial Coordinator Reference number: 1570
Last update: 06-10-2020, 16:14
Region: Braine-l'Alleud
Sector: IT / Pharma
Job description
IT TSCC Industrial Framework :

In today’s world, and even more with digital transformation and Manufacturing 4.0 ambition, technologies (digital product, smart devices, IoT, ….) are everywhere and part of complex and interconnected landscape opened to external threats. This requires cyber vigilance where IT has the mandate to take control on all technologies including industrial ones and ensure compliance with quality and security standards. We developed an IT TSSC Framework, made of:

• a set of standard rules (service definition, requirements and standards (specification, SOP) to which any industrial technology will have to comply)
• an IT Industrial digital governance
The IT TSCC Industrial Coordinator is the “guardian” of this framework and will have to apply it within any industrial initiative such as the building of a modern biological production factory: Inflexio (see below).

Trustworthiness
Being transparent (to the extent possible) about how an application functions, how the user’s data is being used and for what purpose and how we meet which regulatory requirements. Being deliberate about ethical considerations of an application.

Security
Ensuring the right safeguards are in place, including the processes to deal with a security incident.

Safety
Ensuring an application does no harm in case of a defect or a breach.

Compliance
Meeting regulatory requirements relevant to the use case of an application including geographical considerations.

Inflexio :
As part of the Accelerate Strategy, The Client has launched InfleXio 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. For scope introduction please refer to the attached picture in related section.
What you’ll do
  • In the context of Inflexio the IT TSSC Industrial Coordinator will be in charge of:
    1. Own, derive and enhance the IT TSSC Industrial Framework for Inflexio by:
    a) Customizing it whenever it is needed
    b) Defining accelerators (templates, deliverables) as much as needed
    c) Tailor the dedicated governance process to the specificities of the project
    d) Assist with the integration of the processes into the digital platforms in use for IT Digital governance
  • 2) Execute the IT TSCC Industrial Framework in the various phases (technology acquisition and design, implementation…) by:
    a) Assessing each and every work package building, utilities, process, ….) managed by the Inflexio project team to evaluate if those contain technologies and which IT services (network, hosting, …) should be provisioned, hence which standard apply.
    b) Publishing the IT TSSC Industrial standard (requirements) to binding partners and guide as well as engage those partners to provide answers against those requirements.
    c) Collecting and reviewing the answers provided by the selected suppliers and provide the next level of specifications.
    d) Coordinating, together with the specific IT Subject Matter Expert (service owner), a formal digital governance review aiming to validate the answers from the supplier to the specific requirements and standards up to their acceptance or managing non-conformity in a risk-based approach.
    e) In partnership with procurement and legal, ensuring that supplier contracts reflect instruction resulting from the compliance or exception to the specifics requirement and standards.
    f) Documenting the specification of the solution in regards of those requirements and standards into a Design Specification as basis for further qualification and testing process.
Profile
  • Education – bachelor or master’s degree (preferably in, Computer Science, biosciences, Engineering …)
  • Language – English, French
  • IT technical skills - Proven experience in IT & OT(+5y)
    - Broad knowledge of IT & OT infrastructure services used in pharmaceutical/manufacturing plant
    - Broad knowledge of IT Security in the context of Industrial technologies
    - Broad knowledge of Industrial, Engineering, automation practices and technologies and their integration and management as part of IT Landscape and standards.
    - Exposure to IT and OT change coordination in a complex industrial landscape
  • IT Management in Compliance and Security
    - Minimum 5 years’ experience and successful track records (at least 2 end-to-end delivery) in IT Compliance, quality and security management in all its aspects: IT infrastructure, IT application with strong focus on Industrial /manufacturing in pharmaceutical, regulated environment.
    - Experience in Third-Party provider assessments
  • Business Knowledge
    - 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)
Required Skills
  • Conceptual thinking, methodic and rigorous
  • Strong in change management, stakeholder engagement, supplier relationship and communication skills
  • Ability to work alone, in full autonomy and analytically in a problem-solving environment
  • Negotiation skills
  • Be accountable and result oriented, striving for Operational Excellence, total quality and best practices
  • 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
  • Be ready to challenge and be challenged
What's in it for you?
  • This mission is a full-time mission, for a minimum of 6 months – extendable, with partial remote working opportunity (up to 1 day / week) – up to re-evaluation according sanitary situation.
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