Remuneration
Not specified
Location
Cork, C, Ireland
Visa sponsorship
Not specified
Job summary
The MES Platform Engineer configures and builds development, test, and production environments, and delivers MES capabilities such as Electronic Batch Records in regulated manufacturing. The role leads Computer System Validation from requirements through business release, supports integrations with DeltaV, ERP, and LIMS, and produces GMP-aligned documentation. It also coordinates platform configuration, testing, change control, and deployment with IT, Quality, service providers, and business teams.
Qualifications
- Bachelor’s degree in engineering, computer science, or a related field.
- At least five years of experience implementing IT solutions, integrating systems, and supporting and validating applications and interfaces in a regulated environment.
- Hands-on experience configuring MES solutions, preferably Emerson Syncade.
- Experience writing validation plans and requirements, preparing design documentation, configuring systems, testing, and troubleshooting.
- Knowledge of 21 CFR Part 11, electronic records and electronic signatures, and data integrity guidelines is beneficial.
- Experience with electronic testing tools such as ALM and Kneat.
- Experience with server and workstation platforms, including Windows 11.
- Experience testing Electronic Batch Record recipes and deploying MES.
- Strong written and verbal communication skills and the ability to build cross-functional relationships.
- Self-motivated, detail-oriented, and well organized, with strong time management skills.
Responsibilities
- Configure and build MES environments for development, testing, and production.
- Provide technical input on MES architecture and configuration decisions.
- Manage Computer System Validation from requirements definition through business release.
- Coordinate software installation and configuration with service providers and IT and Quality teams.
- Own server installation, security configuration, administration settings, and access permissions.
- Support integration design and testing between MES and adjacent systems, including DeltaV, ERP, and LIMS.
- Prepare validation documentation in accordance with site procedures and GMP guidelines.
- Execute and review test scripts, analyze results, and assess them against predefined criteria.
- Work with business teams to implement procedural controls addressing testing issues.
- Initiate and implement change control in line with quality and data integrity standards.
- Recommend platform changes and improvements, and prioritize work against project schedules.
- Follow environmental, health, and safety procedures and assist with incident investigations.
Skills
Windows
Degrees
Bachelor’s degree in engineering, computer science, or a related field
Industry
Pharmaceutical API manufacturingRegulated environments
Relocation
No