CSV Engineer

2 days ago

Cork, Cork, Ireland Cognizant Life Sciences Manufacturing Full time

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:

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

  1. Experience in analysing and challenging software to identify gaps.
  2. Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines is desirable.
  3. 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 Automation Engineer job, please contact Cognizant today.

Seniority level

Associate

Employment type

Full-time

Job function

Pharmaceutical Manufacturing

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