CSV Engineer / Analyst

consultpharmatek • Concord, NC, US

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Concord, United States | Posted on 07 / 30 / 2024

Industry : Pharma / Biotech / Clinical Research
Job Type : Full time
Work Experience : 5+ years
City : Concord
State / Province : North Carolina
Country : United States

Job Description

Responsible for general lab instrument validation requirements. Candidates should have worked in a lab or have experience in lab validation for at least 1-2 years.

Expertise in CSV is required for this role.

Candidate must have a strong personality.

Onsite work required 4 days a week.

Ability to create various validation documents and understand data integrity is essential.

Minimum 10+ years of experience in related fields.

Requirements

Support validation activities for local and global systems.

Experience in developing and maintaining validation documentation, including validation plans, test protocols, test scripts, and summary reports, in accordance with SOPs and regulatory standards.

Coordinate technical evaluations with site SMEs for new and existing systems from a DI and CSV perspective.

Coordinate with cross-functional teams to ensure validation activities are aligned.

Perform data integrity gap assessments and develop remediation plans for computerized systems.

Create CAPAs, Deviations, and Change Requests using ServiceNow and Trackwise.

Experience with HPALM for authoring and executing test scripts.

Experience in supporting computer validations related to SDLC deliverables.

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Csv • Concord, NC, US