CSV Engineer

Cognizant Life Sciences Manufacturing; Cork; On-site; EUR 60,000 - 90,000; Full time

Job summary

Cognizant Company in Ireland is seeking a Lab CSV Engineer to validate lab systems within QCL Labs and Manufacturing Operations on a long-term contract.

The role requires experience with validating lab equipment, knowledge of 21 CFR Part 11, data integrity, and strong communication to work across cross-functional teams ensuring GMP-aligned compliance.

Qualifications

• Minimum 5 years’ experience supporting and validating lab equipment
• Knowledge of 21CFR Part 11 requirements and data integrity is desirable
• Strong oral and written communication and cross-functional collaboration

Responsibilities

• Manage lab equipment validation projects from software install to business release
• Prioritize CSV activities in line with project schedule and monitor budgets
• Generate validation documentation (Design Spec, Configuration Spec, Testing, Security Plan, TRR) per GMP
• Review software release notes and ensure correct configuration
• Coordinate with service providers to confirm instrument software installation
• Define user permissions and data naming conventions
• Execute test scripts, analyze results and determine pass/fail against criteria
• Implement Change Control activities and procedural controls with QA
• Recommend improvements based on testing outcomes

Skills

Communication skills

Attention to detail

Independent worker

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