CSV Engineer

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

Job summary

Cognizant Life Sciences Manufacturing in Ireland is seeking an experienced Lab CSV Engineer to validate laboratory systems in GMP environments. The role focuses on validation of Lab Systems, supporting newly purchased instruments, and maintaining compliance within a collaborative Computerised Instruments team.

Responsibilities include managing validation projects from software install to release, generating Design, Configuration, Testing, and Security documentation, and coordinating with service

Qualifications

• Minimum 5 years' experience supporting and validating lab equipment, updating documentation, system testing, troubleshooting.
• Experience of analyzing and challenging s/w to identify gaps. Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines is desirable
• 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, both within and outside of the laboratory area

Responsibilities

• Manage lab equipment validation projects from software install to business release
• Prioritize CSV activities in line with the project schedule and monitor budgets
• Generate computer system validation documentation, e.g. Design Spec, Configuration Spec, Testing, Security Plan, Test Summary Report, in accordance with site procedures and GMP guidelines
• Review of software release notes
• Liaise with service providers to determine successful installation of instrument software and ensure correct configuration
• Determine any specific configurations for the software, e.g. how data is saved and named
• Understand and define user permissions
• Execute test scripts, analyse 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

Skills

Lab equipment validation

CSV testing

GMP compliance

21 CFR Part 11

Documentation

Communication

Independent work

Job description

Cognizant Company 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 optimised 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.

About the Role

The Lab Computer System Validation Engineer will be responsible for the validation of Lab Systems in QCL Labs and Manufacturing Operations. We are seeking an enthusiastic and experienced Lab CSV Engineer to join our team on a long-term contract basis. The Lab CSV Engineer will provide systems validation and compliance expertise for newly purchased instruments and support of existing instruments. The position will work within a collaborative Computerised Instruments 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 lab equipment validation projects from software install to business release
• Prioritize CSV activities in line with the project schedule and monitor budgets
• Generate computer system validation documentation, e.g. Design Spec, Configuration Spec, Testing, Security Plan, Test Summary Report, in accordance with site procedures and GMP guidelines
• Review of software release notes
• Liaise with service providers to determine successful installation of instrument software and ensure correct configuration
• Determine any specific configurations for the software, e.g. how data is saved and named
• Understand and define user permissions
• Execute test scripts, analyse 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

Qualifications

• Minimum 5 years' experience supporting and validating lab equipment, updating documentation, system testing, troubleshooting
• Experience of analyzing and challenging s/w to identify gaps. Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines is desirable
• 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, both within and outside of the laboratory area

Required Skills

• Strong oral and written communication skills
• Detail-oriented and excellent organizational skills
• Ability to work independently and collaboratively

Preferred Skills

• Experience in a pharmaceutical API manufacturing operation or a regulated environment
• Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines