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Strong employer brand and metro location increase applicant density despite niche regulatory specialization.
Highly specialized pharma CSV and GxP focus limits transferability across industries.
Explicit 8+ years CSV experience, 3+ years managing projects, and mandatory GxP/regulatory skills.
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Lead and participate in computer system validation (CSV) activities for multiple GxP applications ensuring regulatory compliance and 'fit for use' prior to production release.
Conduct risk and impact assessments, author validation deliverables including plans and summary reports, and support system lifecycle processes and audit inspections.
Identify opportunities to simplify and automate CSV activities and collaborate with IT teams to implement improvements.
Bachelor's degree in Computer Science, Engineering, or Life Sciences.
8-10+ years of experience in computer systems validation within the pharmaceutical industry, including at least 3 years managing CSV projects.
Mandatory knowledge of IT testing practices and methodologies in Pharma GxP, Electronic Records and Electronic Signature regulations, Data Integrity principles, and GAMP methodology.
Excellent English communication skills including technical documentation and presentations.
Experienced in validating systems such as CTMS, eTMF, ServiceNow, Veeva, Qumas, SAP, MES, PV, or Regulatory Submission systems is preferred.
Proficient in general IT infrastructure and application architecture including cloud and networks with familiarity of test management tools like ALM and optionally test automation tools.
Capable of working independently with minimal supervision, making decisions impacting multiple teams, and driving continuous improvement in CSV processes.