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Remote CSV Consultant (Computer Systems Validation Expert) Job Opening In Myrtle Point OR – Now Hiring Healthcare staffing Pros LLC


Job description

Job Description Job Description Contract Duration: 3–6 Months Compensation: $40/hour (Remote, W-2 or 1099) Location: Remote About the Role We are seeking a CSV Consultant (Computer Systems Validation Expert) to support validation activities in regulated industries such medical devices, and biotechnology.

The ideal candidate will be an experienced professional with a strong command of FDA 21 CFR Part 11 , GAMP 5 , and GxP requirements.

This role involves the full lifecycle of validation — from planning and writing detailed validation protocols to executing tests, documenting outcomes, and ensuring systems maintain data integrity and regulatory compliance.

Key Responsibilities Plan, write, and review validation protocols and related documentation for computer systems.

Draft and maintain test scripts , IQ/OQ/PQ protocols , and validation reports .

Conduct and document testing activities to verify systems function as intended and meet all regulatory and business requirements.

Ensure data integrity and adherence to FDA 21 CFR Part 11 , GAMP 5 , and GxP standards.

Collaborate with Quality Assurance, IT, and Regulatory Affairs teams to maintain compliance and support internal and external audits.

Develop and maintain validation documentation , including validation plans, specifications, standard operating procedures (SOPs), and risk assessments.

Support continuous improvement in validation and documentation processes.

Industries & Work Environments Pharmaceutical and medical device manufacturing Biotechnology and life sciences sectors Clinical and laboratory environments Required Skills & Qualifications Proven experience in Computer Systems Validation (CSV) within regulated industries.

Strong technical writing skills, especially in protocol development and documentation .

In-depth understanding of quality assurance , quality control , and software validation .

Working knowledge of risk management principles and validation methodologies.

Familiarity with automation tools and electronic systems (preferred but not required).

Why Join Us 100% remote position with flexible scheduling.

Opportunity to collaborate with leaders in life sciences and regulatory compliance .

Engage in mission-driven validation projects that ensure patient safety and product quality.

To Apply: Please submit your resume and a brief summary of your validation and protocol writing experience, including systems or tools you’ve supported.

Required Skill Profession

Other General


  • Job Details

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Unlock Your Remote CSV Potential: Insight & Career Growth Guide


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