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CSV Engineer

The Denzel Group - Reston, VA

Posted 19 days ago

3 people have applied



Job Description

The Denzel Group, an award-winning search firm, has been chosen to work with a Pharmaceutical industry leader in Maryland on their quest for a talented CSV Engineer.

In this role, you will oversee and execute the validation of new systems, review existing systems, execute change control procedures, ensure data integrity and maintain CSV documentation.

Responsibilities

Ensure computer system compliance with regulations such as GAMP 5, FDA Title 21 Code of Federal Regulations (CFR)

Part 11 and Annex 11.

Author and revise SOPs and WIs related to stand alone software validation and testing.

Act as the SME on CSV procedures, techniques, and regulatory compliance.

Lead and execute CSV activities for existing and new computer systems Respond to questions by auditors, both internal and external.

Evaluate proposed changes to existing systems and proposals for new systems, to determine risk and compliance.

Recommend actions for deviations and nonconforming systems.

Requirements4+ years CSV experience in a GMPGLP environment.

Experience assessing the impact of technology upgrades on applications, security, and related processes.csv, computer systems validation, engineer, specialist, manager, analyst, gmp, gxp, glp, sop, change control.



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