Job Description

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Vale Group has partnered with a company in the life sciences industry, based in Scottsdale, AZ, which is actively searching for an experienced Computer System Validation (CSV) Engineer to work onsite. This opportunity offers competitive compensation based on experience and is ideal for candidates with advanced expertise in CSV practices, regulatory compliance, and lifecycle management of GxP systems.

Benefits of the Computer System Validation (CSV) Engineer role include:

Excellent career growth opportunities along with a competitive benefits package.

Requirements of the Computer System Validation (CSV) Engineer:
•Bachelor's degree in Engineering, Sciences, or a related field.
•A minimum of five years of experience in Computer System Validation, ideally within the life sciences, pharmaceutical, or medical device sectors.
•Comprehensive knowledge of FDA and cGMP regulations, including 21 CFR Part 11 compliance.
•Proficiency in modern and risk-based validation methodologies and data integrity principles.
•Proven ability to work independently and collaboratively with IT, QA, and various stakeholders.
•Experience in qualifying and auditing external vendors, as well as participating in FDA inspections and third-party audits.
•Exceptional technical writing and documentation skills for creating validation plans, test scripts, risk assessments, and SOPs.

Responsibilities of the Computer System Validation (CSV) Engineer:
•Lead the design, planning, and execution of CSV activities for GxP systems in a regulated environment.
•Collaborate with application owners to ensure systems meet GxP compliance and regulatory standards.
•Develop and enhance CSV documentation, including validation protocols, risk assessments, and reports.
•Implement and maintain IT procedures adhering to data integrity requirements for handling raw data systems.
•Oversee vendor qualifications and internal/external audits to ensure compliance with company policies and industry regulations.
•Support the CAPA process, remediation activities, and data integrity initiatives within the CSV program.
•Contribute to continuous improvement efforts and ensure alignment with corporate validation objectives.
•Provide support during FDA inspections, third-party audits, and other regulatory engagements.

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