Pharma MES Recipe Engineer — Manufacturing & Validation

Cognizant Life Sciences Manufacturing; Cork; On-site; EUR 70,000 - 95,000; Full time

Job summary

Cognizant Life Sciences Manufacturing is seeking an MES Recipe Author/Software Engineer to join our Cork site. You will design, configure and support MES recipes and related modules, collaborate with ERP, Automation and Lab teams, and help validate changes in a GMP environment.

Prior MES experience is valued; strong communication and independent work style are essential. The role involves ensuring high quality documentation, interface support, and ongoing improvement of manufacturing IT systems

Qualifications

• Knowledge of programming and Visual Basic with experience in configuration management and deployment of developed code.
• Minimum 3-5 years’ experience in supporting IT applications.
• Minimum 2 years’ experience in a regulated environment.
• Minimum 3-5 years hands on experience with requirements gathering, design documentation, test case development, system & integration testing, COTS implementations and validation deliverables
• MES Recipe Authoring experience, knowledge of the Emerson Syncade MES solution would be an advantage but not required.
• MS SQL server experience would be an advantage
• Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally.
• The successful candidate must be delivery focused and has experience of working across multiple business & functional teams.
• Ability to work independently and in a team environment

Responsibilities

• Development, implementation and support of MES recipes.
• Produce high-quality, well documented configuration that is easily maintainable.
• Configure and support interfaces to ERP, Automation and Lab systems.
• Investigate and troubleshoot problems and propose changes or improvements.
• Implement system design changes in line with GMP practices and Quality Standards.
• Translate business requirements into design and perform testing of MES recipes and changes.
• Generate validation documentation per site procedures and GMP guidelines.
• Collaborate across MES team and other functions; future Out of Hours support.

Skills

Programming

Visual Basic

MS SQL

IT experience

Delivery focus

Independent/team work

Tools

Emerson Syncade MES

Job description

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 Recipe Author/Software Engineer who will be part of a growing MES team. The MES System supports Electronic Batch Records at a large multi-national Biotech manufacturing facility in Cork.

The Software Engineer will be responsible for design and configuration of MES recipes in the Manufacturing site. In addition to this role, s/he may be required to configure and support the MES Weigh and Dispense and Equipment Management modules. S/he will need to have experience of supporting IT applications. S/he is expected to be self-motivated and develop an understanding of the business.

Experience of working in a pharmaceutical API manufacturing operation is desirable.

Responsibilities:

• Development, implementation and support of MES recipes.
• The ability to produce high-quality, well documented configuration that is easily maintainable
• Work with various site teams to configure and support interfaces to other systems that MES interacts with such as ERP, Automation and Lab systems.
• Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements
• Implement system design changes in accordance with company Quality Standards and Practices
• Translate business requirements into design and perform testing of new MES recipes and changes
• Generate computer system validation documentation in accordance with site procedures and GMP guidelines
• Recognise the importance of the quality control function in pharmaceutical production, the MES Software Engineer should display a high level of integrity in the performance of his/her work.
• S/he should be capable of relating well to other people with whom s/he comes in contact, both within and outside of the MES Team
• The role will evolve to require Out of Hours Support in the future

Requirements:

• Knowledge of programming and Visual Basic with experience in configuration management and deployment of developed code.
• Minimum 3-5 years’ experience in supporting IT applications.
• Minimum 2 years’ experience in a regulated environment.
• Minimum 3-5 years hands on experience with requirements gathering, design documentation, test case development, system & integration testing, custom off the shelf (COTS) implementations and validation deliverables
• MES Recipe Authoring experience, knowledge of the Emerson Syncade MES solution would be an advantage but not required.
• MS SQL server experience would be an advantage
• Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally.
• The successful candidate must be a highly motivated individual who is delivery focused and has experience of working successfully across multiple business & functional teams.
• Ability to work independently and in a team environment

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.