Technical Business Analyst - MES & Digital Solutions
On-siteBirmingham, England, United Kingdom
Birmingham, England, United KingdomOn-siteFull TimeBachelors DegreeLarge
Full TimeBachelors DegreeLarge
Job Summary
Implement and support Rockwell PharmaSuite MES, including electronic batch records and manufacturing process digitisation. Analyse business processes, translate requirements into functional specifications, and drive solution design, testing, validation, and deployment. Collaborate with manufacturing, quality, engineering, and IT stakeholders to ensure operational compliance with regulatory standards like 21 CFR Part 11. Maintain system performance, investigate incidents, and coordinate support activities for continuous improvement. Work within the Digital Productivity team to evaluate emerging technologies such as workflow automation and AI.
Required Qualifications
- Bachelor's degree
- At least five years of relevant experience in business systems analysis, requirements gathering, solution design, system implementation or application support
- Equivalent professional experience
- Strong hands-on experience with Rockwell Automation PharmaSuite MES or any other MES system, including recipe design and configuration, system testing, implementation, troubleshooting and production support
- Proven experience supporting PharmaSuite or any other MES within a regulated manufacturing environment, including electronic batch records, validated system changes and collaboration with Quality, Manufacturing, Engineering and IT teams
- Experience implementing and supporting electronic batch record solutions in a regulated manufacturing environment
- Understanding of PharmaSuite system architecture, interfaces and integration with ERP and operational technology systems
- Experience investigating MES incidents, performing root-cause analysis and coordinating resolution with internal teams, suppliers and support partners
- Experience managing PharmaSuite changes through appropriate testing, validation, documentation and change-control processes
- Strong knowledge of ERP systems and their integration with manufacturing applications
- Knowledge of operational technology systems and how equipment, automation and control systems interface with MES applications
- Experience with data analysis, reporting tools and relational database technologies, including SQL or Oracle
- Experience working with GxP-regulated systems and a strong understanding of computerised system validation, data integrity, 21 CFR Part 11 and, where applicable, EU GMP Annex 11 requirements
- Experience supporting system testing activities, including test-script preparation, system integration testing, user acceptance testing and defect management
- Knowledge of software development and system-delivery methodologies, including Agile and Waterfall
- Understanding of IT service-management practices, including incident, problem, change and release management
- Proven ability to gather, analyse and document complex business, operational and technical requirements
- Experience translating business requirements into clear functional and technical specifications
- Experience mapping manufacturing processes and identifying opportunities for digital improvement
- Ability to support solution design, configuration, testing, validation, deployment and user adoption
- Good project coordination and workstream-delivery skills, with experience supporting cross-functional initiatives
- Experience working with external suppliers, system integrators and application-support partners
- Ability to identify project and operational risks, communicate issues clearly and escalate them appropriately
- Strong analytical, investigative and problem-solving capabilities
- Strong written and verbal communication skills, with the ability to communicate effectively with technical and non-technical stakeholders
- Good stakeholder-management, workshop-facilitation and interpersonal skills
- Ability to work effectively across Manufacturing, Quality, Engineering, IT and external supplier teams
- Strong organisational skills and the ability to manage multiple priorities
- Ability to work independently and take ownership of assigned activities
- Ability to guide colleagues and provide technical leadership within areas of expertise
- Proficiency in Microsoft Office applications and relevant business-analysis, documentation and collaboration tools
- Fluent written and spoken English
- Work Schedule Standard (Mon-Fri)
- Office Job
Desired Qualifications
- A degree in Computer Science, Information Technology, Engineering, Business Administration or a related discipline is preferred
- Experience with systems such as IFS is beneficial
- Additional desirable experience integrating MES with ERP, laboratory, warehouse, reporting or shop-floor automation systems
- Experience implementing digital productivity solutions, workflow automation, artificial intelligence or low-code technologies
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