Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

As a Technical Business Analyst within the Digital Productivity team at Thermo Fisher Scientific in Birmingham, UK, you will support the implementation, operation and continuous improvement of digital manufacturing solutions.

A key focus of the role will be the implementation and ongoing support of the Rockwell PharmaSuite Manufacturing Execution System (MES), including the introduction of electronic batch records and the digitisation of manufacturing processes. You will work closely with manufacturing, quality, engineering, IT and other business stakeholders, as well as external suppliers and support partners, to ensure solutions meet operational, technical and regulatory requirements.

You will analyse business processes and requirements, translate them into clear functional and technical specifications, and support solution design, configuration, testing, validation, deployment and user adoption. Following implementation, you will help maintain system performance, investigate and resolve issues, coordinate support activities and identify opportunities for further improvement.

The role requires a combination of technical understanding, business analysis skills and stakeholder management. You will contribute to projects and continuous improvement initiatives while ensuring that systems and processes remain compliant with applicable quality and regulatory standards.

As part of the wider Digital Productivity team, you will also support the evaluation and implementation of digital tools that improve efficiency, reduce costs and enhance the employee and customer experience. These may include workflow automation, artificial intelligence and other emerging technologies.

REQUIREMENTS:

Education and experience

• A bachelor’s degree with at least five years of relevant experience in business systems analysis, requirements gathering, solution design, system implementation or application support.

• Equivalent professional experience may also be considered.

• A degree in Computer Science, Information Technology, Engineering, Business Administration or a related discipline is preferred.

Essential MES 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.

Essential technical and regulatory knowledge

• Strong knowledge of ERP systems and their integration with manufacturing applications. Experience with systems such as IFS is beneficial.

• 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.

Business analysis and delivery experience

• 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.

Skills and competencies

• 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.

Additional desirable experience

• 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.