CSV Engineer

Cognizant Technology Solutions Corporation; Cork; Hybrid; EUR 50,000 - 70,000; Full time

Job summary

A leading technology company is seeking an experienced CSV Engineer for a full-time hybrid role in Cork, Ireland. The successful candidate will manage lab system validation projects and work on compliance for laboratory equipment. Applicants should have at least 3 years of relevant experience, excellent communication skills, and familiarity with regulatory requirements. This position offers a favorable salary and flexible working arrangements, providing a collaborative working environment.

Qualifications

• Minimum 3 years of experience supporting and validating lab equipment.
• Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines is desirable.

Responsibilities

• Manage lab equipment validation projects from software install to business release.
• Prioritize CSV activities in line with project schedule and monitor budgets.
• Create Design Spec, Configuration Spec, Testing, Security Plan, and Test Summary Report.
• Review software release notes.

Skills

Experience in analysing and challenging software to identify gaps

Excellent oral and written communication skills

Ability to build relationships cross-functionally

Job description

Cognizant is seeking an agile, passionate and experienced CSV Engineer to join our team on a long-term basis. This full-time hybrid role comes with a favorable salary and the opportunity to explore flexible working arrangements. You'll be responsible for validating Lab Systems in QCL Labs and Manufacturing Operations.

As a CSV Engineer, you will provide systems validation and compliance expertise for newly purchased instruments and support of existing instruments. You will work within a collaborative Computerised Instruments team and must have excellent communication and interpersonal skills with the ability to work on your own initiative.

In your first few weeks in this Lab System Validation Engineer role, you can expect to:

• Manage lab equipment validation projects from software install to business release
• Prioritize CSV activities in line with the project schedule and monitor budgets.
• Design Spec, Configuration Spec, Testing, Security Plan, and Test Summary Report, in accordance with site procedures and GMP guidelines
• Review of software release notes.

To apply for this Lab CSV Engineer role, you will need at least 3 years of experience supporting and validating lab equipment, updating documentation, system testing, and troubleshooting. You will also require the following:

• Experience in analysing and challenging s/w to identify gaps
• Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines is desirable
• Excellent oral and written communication skills, with the proven ability to communicate and build relationships cross-functionally.

To apply for this hybrid full-time CSV Engineer job, please contact Cognizant today. Please refer any friends or colleagues for this role or direct them to our Careers page on our website.