About the Role
The MES Platform Engineer role combines hands-on technical responsibility with end-to-end delivery ownership, spanning system validation, platform configuration, and the introduction of new MES capabilities such as environment builds and Electronic Batch Records. The successful candidate will work as part of a cross-functional team while retaining the autonomy to manage and progress their own activities independently. The position will work within a collaborative team and will be required to have excellent communication/interpersonal skills with the ability to work on their own initiative. Experience of working in a pharmaceutical API manufacturing operation or a regulated environment is desirable.
Responsibilities
- Configure and build out MES Platform environments (Dev/Test/Production) in line with project and validation lifecycle requirements
- Provide technical input into MES Platform architecture and configuration decisions during project implementation
- Manage the Computer System Validation (CSV) aspect of MES Platform projects from requirements definition to business release
- Liaise with service providers and both local and global IT & Quality teams to ensure correct software installation and configuration
- Own server installation and system-related activities, e.g. security configuration, admin settings, access permissions
- Support integration design and testing between the MES Platform and adjacent systems (e.g. DeltaV, ERP, LIMS)
- Generate computer system validation documentation in accordance with site procedures and GMP guidelines
- Review and execute test scripts, analyze test results, and determine acceptability of results against pre-determined criteria
- Work with the business to identify and implement procedural controls to mitigate issues found during testing
- Initiate and implement Change Control activities in accordance with Quality Standards and Practices and Data Integrity standards.
- Determine solutions or recommendations for changes and/or improvements
- Prioritize validation and platform build activities in line with the project schedule
- Collaborate with Global IT and Quality teams
- Follow all relevant Environmental, Health and Safety procedures and assist in incident investigations as required
Qualifications
- Bachelors’ degree in Engineering, Computer Science, or related field with 5+ years’ experience implementing IT solutions, systems integration, support & validating IT applications and interfaces within a regulated environment.
Required Skills
- Hands on experience of MES solutions (preferably Emerson Syncade) including system configuration.
- Experience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting
- Knowledge of 21CFR Part 11 requirements, ER/ES, and data integrity guidelines beneficial
- Experience of electronic testing tools such as ALM and Kneat
- Experience of server and workstation platforms and working in a Win 11 environment
- Experience in EBR recipe testing and MES deployment
- Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally.
- Self-motivated, detail-oriented, and excellent organizational and time management skills
- Capable of relating well to other people with whom s/he comes in contact