Remote CSV Consultant (Computer Systems Validation Expert)Healthcare Staffing Pros LLC • Remote, Oregon, United States
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Remote CSV Consultant (Computer Systems Validation Expert)
Healthcare Staffing Pros LLC
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- Remote, Oregon, United States
- +1
- +2
- Remote, Oregon, United States
À propos
*Compensation:* $35 - $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 as pharmaceuticals, 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.
Job Type: Contract
Pay: $35.00 - $40.00 per hour
Expected hours: 40 per week
Work Location: Remote
Compétences idéales
- GxP
- Risk Management
Expérience professionnelle
- QA Test Automation
Compétences linguistiques
- English
Avis aux utilisateurs
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