Procurement and Manufacturing

Position: Sr. Business System Analyst, Oracle ERP Fusion and other Manufacturing systems .

Description:

This position will serve as a dedicated, on-site operational resource embedded within Clients' Cell and Gene Therapy manufacturing and laboratory environment. Functioning as the primary liaison between end users, IT, and business stakeholders, this individual will provide hands-on functional support across Oracle Fusion Cloud applications, with a concentration in Product Information Management (PIM), Supply Chain Management (SCM), Manufacturing, Quality Management, Inventory, label printing, and system integrations. The role extends to ancillary manufacturing systems in use at the site, ensuring continuity of operations across the broader manufacturing technology landscape.

This is not a configuration-heavy consulting role. The ideal candidate brings deep SCM/Mfg. Business and Oracle Fusion functional knowledge, the instincts of a seasoned super-user, and the domain fluency to operate effectively within a GxP-regulated environment. This individual will serve as the eyes and ears of the ERP Applications leadership team at the manufacturing location, proactively surfacing issues, translating operational realities into actionable requirements, and ensuring that technology supports science.

Responsibilities:

Operational Support

Provide day-to-day functional support to manufacturing, lab, quality, and supply chain end users across Oracle Fusion modules including PIM, SCM, Manufacturing, Quality Management, Inventory Management, integrations, and label printing, as well as ancillary manufacturing systems and applications.
Act as the first point of escalation for application issues at the manufacturing site; triage, troubleshoot, and resolve or route incidents with urgency and precision.
Coordinate with business owners, functional leads, and IT peers to ensure cross-functional system integrity and operational continuity.
Perform functional validation of system behavior following patches, Redwood page migrations, updates, or configuration changes; document findings and communicate impact to the ERP Applications team.
Analyze business scenarios and identify opportunities for improvement through automation and process redesign.
Proactively stay abreast of relevant technologies and digital trends to support the company’s evolving operational needs.

Business Requirements and Process Design

Engage with manufacturing, quality, and operations stakeholders to elicit both stated and unstated business requirements; translate operational needs into clear, structured functional and technical specifications.
Think holistically across end-to-end processes; identify upstream and downstream impacts before recommending solutions or escalating to configuration or development resources.
Document current-state and future-state process flows, including end-to-end process models and visual depictions of system and data flows, to facilitate requirements and design discussions.
Participate in fit-gap analysis discussions to align system capabilities with evolving business needs; document configuration, application functionality, and integration modifications required to support business requirements.
Collaborate with IT colleagues to align and verify technical requirements and to establish a robust post implementation support model.
Serve as an informed voice at the manufacturing site for IT and ERP leadership, providing grounded, site-level context to design and prioritization decisions.

Testing, Training, and Change Management

Author, maintain, and execute functional test scripts covering core manufacturing and supply chain scenarios; coordinate and support user acceptance testing (UAT) cycles.
Develop and deliver role-based end user training materials; conduct live training sessions for new and existing users at the manufacturing site.
Support change management activities associated with system enhancements, new module rollouts, and process redesigns impacting site operations.

GxP Compliance and Validation

Apply working knowledge of GxP regulations, Computer System Validation (CSV), and 21 CFR Part 11 requirements across all support, testing, and documentation activities.
Support the authoring and review of validation deliverables including IQ/OQ/PQ protocols, test scripts, and traceability matrices.
Demonstrate familiarity with Electronic Batch Records (EBR) and Master Batch Records (MBR) and their operational relationship to manufacturing execution and ERP systems.
Adhere to change control, documentation, and audit trail standards required in a regulated Cell and Gene Therapy manufacturing environment.

Minimum Requirements:

BS/BA in computer science, engineering, information technology or relevant field with 5+ years of IT business and system analyst experience; and/or 8+ years of IT experience with at least 4+ years as a business analyst in a regulated commercial or pharmaceutical, medical device, or medical systems field.
Direct operational experience supporting a Cell and Gene Therapy or advanced biologics manufacturing environment.
Working knowledge of GxP regulations, CSV practices, EBR/MBR frameworks, and 21 CFR Part 11 compliance requirements.
Familiarity with RFSmart or comparable mobile warehouse and receiving solutions integrated with Oracle Fusion.
Proven ability to elicit, analyze, and document complex business requirements independently, with the judgment to identify unstated needs and end-to-end process implications.
Demonstrated experience authoring and executing functional test scripts, coordinating UAT, and delivering end user training.
Strong interpersonal and communication skills; ability to build credibility with bench-level users and translate site-level realities to IT leadership.
Ability to work on-site at the manufacturing and laboratory facility for the full duration of the engagement.
Highly proficient in written and oral communication skills and creating process Flows

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