About the project
We are looking for a Senior Business Analyst / Functional Architect with strong Pharma Manufacturing expertise to join a global initiative within Pharma Technical Operations.
The project focuses on the development and evolution of an Enterprise Recipe Management capability supporting pharmaceutical manufacturing processes. The successful candidate will act as a Manufacturing Domain Expert, working at the intersection of business, manufacturing operations, IT architecture and technical delivery teams.
The role is focused on identifying and assessing high-value business opportunities, understanding complex cross-system manufacturing processes, defining improvement opportunities and translating business needs into detailed functional requirements.
You will work closely with business stakeholders, domain leads, system owners and technical teams to understand existing processes and data flows, identify gaps and dependencies, and design scalable solutions across the manufacturing IT landscape.
The environment includes systems such as Emerson PKM, MES, LIMS, ERP/SAP S/4HANA, PLM, ELN and DeltaV, with a strong focus on GxP compliance, data interoperability and integration.
The role also provides an opportunity to identify and support the implementation of Generative AI / Machine Learning use cases within pharmaceutical manufacturing.
Your responsibilities
- Act as a Pharma Manufacturing Domain Expert and subject matter expert for business and technical stakeholders.
- Conduct interviews and workshops with business stakeholders, domain leads and system owners to understand business needs, processes and pain points.
- Identify and pre-assess business opportunities in terms of business value, complexity, effort, dependencies and potential impact.
- Support the creation of robust business cases and prioritization of improvement initiatives.
- Analyse and document end-to-end manufacturing business processes and cross-system data flows.
- Design and document process flows, functional requirements, business requirements and non-functional requirements.
- Translate business needs into detailed EPICs, Features and User Stories for Agile delivery teams.
- Define functional specifications for Emerson PKM configurations, integrations and reporting capabilities.
- Analyse and document integrations between manufacturing systems, including MES, LIMS, ERP, PLM, ELN and DeltaV.
- Ensure that proposed solutions support GxP compliance, data integrity, interoperability and relevant pharmaceutical manufacturing standards.
- Facilitate communication and alignment between business stakeholders, architects, developers and other technical teams.
- Establish a common understanding of business processes, data flows, system capabilities, integration requirements and architectural decisions.
- Create and maintain functional and technical documentation, including functional specifications and Architecture Decision Records (ADRs).
- Identify gaps between current and target-state processes and systems and propose practical improvement opportunities.
- Support the project team during solution design, refinement, implementation and delivery.
- Identify relevant Generative AI / ML use cases within the manufacturing domain and support their assessment and implementation.
- Proactively manage discussions, resolve conflicting viewpoints and de-escalate challenging situations while maintaining focus on business outcomes.
Our requirements
- 5–10 years of professional experience as a Business Analyst, Functional Architect, Functional Consultant or similar role within Pharmaceutical, Life Sciences or another highly regulated manufacturing environment.
- Bachelor's degree in Computer Science, Information Systems, Engineering or equivalent practical experience.
- Hands-on understanding of product recipe design and parameter definition within a manufacturing environment.
- Practical experience with manufacturing systems such as MES, PLM, LIMS, ERP or similar platforms.
- Strong understanding of pharmaceutical manufacturing processes, ideally covering drug substance and/or drug product manufacturing.
- Ability to analyse complex business processes and translate business needs into structured functional and non-functional requirements.
- Experience creating EPICs, User Stories, functional specifications and process documentation.
- Strong understanding of system and data integration concepts.
- Ability to analyse and document end-to-end business processes and cross-system data flows.
- Excellent communication and stakeholder management skills.
- Proven ability to collaborate effectively with global, cross-functional and distributed teams.
- Strong analytical and problem-solving mindset.
- Ability to facilitate discussions, manage different stakeholder perspectives and de-escalate conflicts while keeping teams focused on outcomes.
- Proven experience working on system integration projects involving technologies/systems such as: Emerson / DeltaV SAP S/4HANA MES LIMS PLM ELN ERP or comparable manufacturing platforms.
- Knowledge of ISA-95 and/or ISA-88 principles.
- Understanding of enterprise-level manufacturing integration architectures.
- Experience with SAFe Agile methodologies.
- Previous experience working for Roche or within a similarly complex, highly regulated Life Sciences environment.
- Strong understanding of data interoperability, reporting standards and business process modelling/mapping.
- Knowledge of SQL databases, relational data structures and reporting systems.
- Experience aligning architecture, business processes and solution design across multiple IT domains.
- Experience working on global or multi-site manufacturing integration programmes.
- Exposure to Generative AI / Machine Learning applications in manufacturing.