Overview
Hybrid
$50 - $60
Contract - W2
Contract - 12 Month(s)
Skills
FDA 21 CFR Part 11
Part 211
Part 820
Job Details
Job Title: IT CSV / CQV Validation Specialist
Location: Boston, MA (Hybrid) Candidates in the US must support EST hours
Experience: Total 8 10 Years | Relevant 5 8 Years
pranayatburgeonitsdotcom
Role Overview
We are seeking an experienced Validation Specialist with a strong background in IT Computer System Validation (CSV) and Commissioning, Qualification & Validation (CQV) within the Pharmaceutical / Life Sciences industry. The ideal candidate will be responsible for leading validation projects, authoring quality documentation, and ensuring compliance with regulatory standards.
Key Responsibilities
Develop, review, and approve validation/quality documentation: protocols, reports, risk assessments, SOPs.
Ensure all deliverables comply with FDA, EMA, GxP, GAMP 5, and ISPE guidelines.
Lead and manage multiple validation and quality projects, defining timelines and deliverables.
Identify project risks and implement mitigation strategies.
Conduct status meetings and prepare progress updates for stakeholders.
Support internal and external audits as a Validation SME.
Collaborate with cross-functional teams and vendors.
Mandatory Skills
IT CSV (Computer System Validation)
CQV (Qualification of Equipment / Systems)
Experience with regulatory frameworks: FDA 21 CFR Part 11, Part 211, Part 820
Hands-on experience with Veeva Quality Docs, ServiceNow, Jira, and Kneat
Proven experience authoring and managing validation documents
Pharma / Life Sciences industry experience is required
Desired Skills
Understanding of latest industry trends and emerging validation technologies.
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