MES Platform Engineer for Pharma 4.0 & Validation

Cognizant Life Sciences Manufacturing; Cork; On-site; EUR 65,000 - 90,000; Full time

Job summary

Cognizant Life Sciences Manufacturing in Cork, Ireland is seeking an experienced MES Platform Engineer to join a growing MES team. The role focuses on validation, IT/OT/IoT integration, and collaboration with global IT and Quality teams in a regulated environment.

You will manage computer system validation for MES projects, coordinate with service providers, and ensure configurations meet GMP guidelines. Strong communication and initiative are essential for success in this position.

Qualifications

• Minimum 5 years’ experience implementing IT solutions, systems integration, support & validating IT applications and interfaces.
• Experience 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.
• Hands on experience of MES solutions (preferably Emerson Syncade) including system configuration.
• Experience of electronic testing tools such as ALM and Kneat.
• Experience of server and workstation platforms and working in a Win 10 environment.
• Experience in EBR recipe testing.
• Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally.

Responsibilities

• Manage the Computer System Validation aspect of MES projects from requirements definition to business release.
• Liaise with service providers and IT team to determine successful installation of software and ensure correct configuration.
• Responsibility for server installations and system related activities e.g., security, admin config settings, access permissions
• Generate computer system validation documentation in accordance with site procedures and GMP guidelines.
• Execute test scripts, analyze test results, and determine the 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
• Determine solutions or recommendations for changes and/or improvements.
• Prioritize validation activities in line with the project schedule.
• Collaborating with global IT and Quality teams
• Following all relevant Environmental, Health and Safety procedures and assist in incident investigations as required.

Skills

Communication skills

Detail oriented

Time management

Tools

ALM

Kneat

Emerson Syncade

Job description

Cognizant Life Sciences Manufacturing in Cork, Ireland is seeking an experienced MES Platform Engineer to join a growing MES team. The role focuses on validation, IT/OT/IoT integration, and collaboration with global IT and Quality teams in a regulated environment.

You will manage computer system validation for MES projects, coordinate with service providers, and ensure configurations meet GMP guidelines. Strong communication and initiative are essential for success in this position.