Summary

Location: Barcelona
#LI-Hybrid

Effectively transform the business requirements into an IT solution design specification, ultimately leading to meeting the customer expectations while assuring solutions are safe, reliable, scalable and flexible.

Act as an advisor providing guidance to improve global business processes, products, services, and software through data analysis on TRD Digital Plant.

Engage with global business leaders and leverage the appropriate Data Digital & IT (DDIT) teams and Functions to determine requirements and deliver data-driven recommendations to improve efficiency and add value

About the Role

Role Responsibilities:

• Ensure consistency and traceability between user requirements, functional specifications, and testing & validation. Support validation and testing as appropriate and ensure adherence to Security and Compliance policies and procedures within Service Delivery scope.
• Keep abreast with internal IT systems and documentation requirements, standards (including quality management and IT security), regulatory environments / requirements (if applicable), DDIT Service Portfolio and with industry best practices in leveraging technologies for the business and taking advantage of reusable products, solutions, and services wherever applicable. Additional specification required for testing.
• Develop project rationale and perform scoping assessments to determine feasibility of projects.
• Highlight/identify gaps in existing functionality and review requirements with stakeholders. Develop a comprehensive requirement specification that will determine the estimate of cost, time and resources to deploy solutions.
• Liaise with the service development team to suggest a high level functional solution.
• Develop project estimates and complete financial model (costs, savings, revenue opportunities, investment horizon, etc.)
• Ensure that relevant stakeholders are involved in specification of new services and/or major upgrades to existing services.
• Ensure the overall user experience is taken into account when designing and deploying new solutions and services.
• Ensure consistency and traceability between user requirements, functional specifications and testing & validation. Support validation and testing (OQ, PQ, UAT...)
• Ensure implemented solutions are according to specifications and fit for purpose. Support super user training.

• University degree in Informatics, Computer Sciences, Life Sciences or similar.
• A minimum of 6+ years of experience in working in the Pharma or IT Industry, particularly experience in the Drug manufacturing IT domain.
• Experience as a business analyst/process expert/ business IT lead superuser/Manufacturing data or Digital position
• Good understanding of business process analysis & design and system architecture concepts.
• Ability to solve complex business process / information challenges.
• Proficient skills in global teams, collaboration, facilitation, negotiation, working in a matrix environment and conflict resolution.

• Understanding of the Manufacturing business processes, drug development experiences an advantage.
• Knowledge of Manufacturing systems including MES systems, and Historian systems is preferred. Knowledge of GXP, 21CFR Part 11 and the CSV lifecycle.
• Prior working experience in TRD and knowledge on TRD business processes is preferred.