<h3>Job Description</h3>
 
We are seeking a CSV Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotech environment.
 
Key Requirements:
<ul>
<li>Hands-on experience with Computer System Validation (CSV)</li>
<li>Strong understanding of GAMP 5 and 21 CFR Part 11</li>
<li>Experience supporting QC laboratory systems and/or manufacturing equipment validation</li>
<li>Ability to develop and review validation lifecycle documents (URS, IQ, OQ, PQ, Risk Assessments, Validation Reports)</li>
<li>Experience working cross-functionally with QA, Manufacturing, Engineering, and IT teams</li>
<li>Strong documentation and communication skills</li>
</ul>
 
 Key Responsibilities
<ul>
<li>:Develop, execute, and maintain CSV documentation and validation protocols for QC and manufacturing systems</li>
<li>.Perform risk assessments and ensure compliance with GAMP 5, 21 CFR Part 11, and GMP requirements</li>
<li>.Review and support validation lifecycle activities, including URS, IQ, OQ, PQ, and validation reports while collaborating with QA, Manufacturing, and IT teams</li>
</ul>
 
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