Business Analyst / Functional Architect – Pharma Manufacturing

Square One Resources is recruiting for a Senior Business Analyst / Functional Architect with expertise in pharmaceutical manufacturing, working within Pharma Technical Operations on a global initiative that focuses on developing and evolving an Enterprise Recipe Management capability supporting pharmaceutical manufacturing processes.

• 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.
• Proven experience working on system integration projects involving Emerson / DeltaV, SAP S/4HANA, MES, LIMS, PLM, ELN, ERP or comparable manufacturing 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.

Nice to have:

• Knowledge of ISA-95 and/or ISA-88 principles.
• Understanding of enterprise-level manufacturing integration architectures.
• Experience with SAFe Agile methodologies.
• 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.

• 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 / Machine Learning 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 outcomes.