MES Platform Engineer

Cognizant Life Sciences Manufacturing; Cork; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Communication skills

Detail oriented

Time management

Outils

ALM

Kneat

Emerson Syncade

Description du poste

Cognizant is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimized to improve operational efficiencies, whilst maintaining compliance.

Our specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT and IoT applications, infrastructures and services.

Operating across 5 continents and with over 300.000 skilled employees, Cognizant partners with the leading Life Sciences companies globally to provide performance improvements, reduced costs and improve time to market. We are your single end to end partner for consultancy, design implementation, optimization and support for all applications in the Pharmaceutical and Biotechnology Manufacturing stack.

CTS are looking for an MES Platform Engineer who will be part of a growing MES team. The MES Platform Engineer 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:

• 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.

Requirements:

• Minimum 5 years’ experience implementing IT solutions, systems integration, support & validating IT applications and interfaces.
• 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
• 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.
• 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

At Cognizant, we engineer modern businesses to improve everyday life because we are dedicated to making a lasting impact. Cognizant (Nasdaq: CTSH) engineer's modern businesses. We help our clients modernize technology, reimagine processes and transform experiences so they can stay ahead in our fast-changing world. Together, we are improving everyday life. See how at www.cognizant.com or @cognizant.