IT TSSC Industrial Coordinator
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 co-operation between IT and OT, as well as cyber vigilance. Client IT has the mandate to take control on computerized systems and technology platforms which encompasses both corporate and industrial components. Our objective is to ensure regulatory compliance driven by our quality, operational and security standards.
Our client developed an IT TSSC Framework , made of :
- standard rules and reference model to which any industrial vendor and solution must comply with;
- an IT Industrial digital governance process condoling the solution lifecycle, from initial need definition up to run and retirement
The IT Industrial Project Coordinator is the “guardian” of this framework and will have to apply it within any industrial initiative and to the building of a modern biological production factory
- TSCC Framework
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.
Ensuring the right safeguards are in place, including the processes to deal with a security incident.
Ensuring an application does no harm in case of a defect or a breach.
Meeting regulatory requirements relevant to the use case of an application including geographical considerations.
- Apply and enforce the IT Industrial Framework by:
- Collaborating with the IT Industrial and Security team in his improvement and enforcement
- Defining accelerators (documentation, templates, deliverables) as much as needed
- Apply the IT Industrial governance process to the specificities of the project
- Assist with the integration of the processes into the digital platforms in use for IT Digital governance
- Execute the IT Industrial Framework in the various project phases (design, build, run) by:
- Assessing each and every work packages (building, utilities, process, …. ) managed by the project team to evaluate if those contain technologies and which IT services ( network, hosting, … ) should be provisioned , hence which standard apply .
- Publishing the IT Industrial requirements to binding partners and guide as well as engage those partners to provide answers against those requirements.
- Collecting and reviewing the answers provided by the selected suppliers and provide the next level of specifications.
- Coordinating, in alignment with IT Infrastructure, Industrial, Manufacturing and Security Subject Matter Expert, a formal architecture and solution 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.
- Engage and formalize recommendation to decision with the IT Industrial Governance board.
- In partnership with procurement and legal, ensuring that supplier contracts reflect instruction resulting from the compliance or exception to the specifics requirement and standards.
- 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
Education – bachelor or master’s degree (preferably in, Computer Science, biosciences, Engineering)
Language – English
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
- 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)
- 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