Csv Specialist

The CSV Specialist is responsible for authoring validation documentation for the remediation of 32 legacy GxP computerized systems. Working under the guidance of an experienced Software Quality Engineer, the specialist writes and executes protocols, composes SOPs, and prepares a comprehensive Validation Summary Report for all systems., * Author Installation Qualification (IQ) and verification protocols to test remediated controls, including user access, audit trails, electronic records, and data integrity.

• Execute protocols, document objective evidence, and address any deviations.
• Compose system operational SOPs and assist the IT Specialist with system administration SOPs.
• Contribute to the development of privilege matrices, configuration specifications, and data integrity controls.
• Prepare a final Validation Summary Report encompassing all 32 systems at the project’s conclusion.
• Revise documents based on feedback from QA reviewers.
• Adhere to SOPs, templates, and document control processes, maintaining good documentation practices.

• 5+ years of experience in the pharmaceutical, biotech, or medical device industry, with at least 1 year in computerized system validation.
• Hands-on experience in writing and executing IQ, OQ, PQ, or verification protocols.
• Working knowledge of 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+).
• Experience in validating or remediating laboratory or manufacturing systems such as LIMS, chromatography data systems, MES, or ERP.
• Strong technical writing skills and attention to detail.

Additional Skills & Qualifications

• Experience in remediating legacy systems post-audit or gap assessment.
• Experience in supporting FDA inspections or client audits.
• Bachelor’s degree in a scientific, engineering, or IT field., Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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