Computer System Validation Engineer
What makes Cognizant a unique place to work? The combination of rapid growth and an international and innovative environment! This is creating many exciting and challenging opportunities for professionals with an entrepreneurial spirit who want to make a difference in this world. Connect to the Future. Join us now!
We are looking for a CSV Engineer to join our Internet of Things team. For more information on our offerings, please click here Get to know us
We offer innovative work, meaningful career paths.
At Cognizant we embrace a well-established set of cultural values, we embrace diversity. We believe it's what helps us thrive. Our goal is to include everyone at the table, and to value and respect their unique voices and backgrounds.
Hear more about Cognizant in this video. Is our passion matching yours?
The work as a CSV Engineer is highly rewarding as you:
Will you strengthen our team?
- Work in projects within Cognizant accounts and provide inputs for alignment within the customer organization
- Drive opportunities in the region and support the sales team with building a healthy pipeline
- Build a team of consultants to drive the Industrial Operations Management team
For the CSV Engineer we are looking for someone who can add value with the following skills and experience:
- 5+ years' experience in the Pharmaceutical or Biotech industries.
- Main responsibility is to execute User Requirements, Design Specification, Functional Specification, Traceability Matrix, Producing Validation Plans, and writing IQ/OQ/PQ protocols and test scripts.
- Experience with CSV of manufacturing and Lab equipment in compliance to FDA and EU standards.
- Experience with EMS systems.
- Knowledge of GMP regulations as well as 21 CFR part 11, EU Annex 11, 210, 211.
- Serving as the SME for the CSV team.
- Ability to work cross functionally with the validation, Quality, and manufacturing team.
- Perform periodic review reports on all equipment as well as change control, GMP, and deviation documentation reviews for the computer systems and EMS systems.
- Data Integrity Experience would be a plus.