IT CSV Engineer

Cognizant is looking for an IT CSV Engineer, and the hybrid role comes with an attractive salary and benefits package, including the chance to join a collaborative team. The IT CSV Engineer will be responsible for the validation of Lab Systems in QCL Labs and Manufacturing Operations. You will provide systems validation and compliance expertise for newly purchased instruments.

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• Manage lab equipment validation projects from software install to business release
  
• Priorities 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 software release notes.
  

To apply for this IT CSV Engineer role, you will need a Bachelor's Degree in the appropriate field of study or equivalent work experience. You will also require:

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

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• You’ll receive an excellent salary and benefits package for your knowledge, expertise and flexibility. At Cognizant, taking care of employees is a priority:
  
• You can pursue innovative career tracks and opportunities here
  
• You can enhance your professional development through education and dedicated training
  
• We’ll give you the skills you need to keep pace with the changing workplace while our compensation, benefits and wellness packages help you stay healthy and plan.
  

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• We strive to provide flexibility wherever possible. Based on this role’s business requirements, this is a Hybrid position, based on our clients site 3 days per week.
  
• The working arrangements for this role are accurate as of the date of posting. This may change based on the project you’re engaged in, as well as business and client requirements. xcfaprz Rest assured; we will always be clear about role expectations.