Job Title: CSV Validation Specialist
📅
Experience:
5+ Years
Overview
We are seeking an experienced
CSV Validation Specialist
to support validation and qualification activities for infrastructure and regulated systems within a GxP environment. The ideal candidate will have strong expertise in computer system validation, infrastructure qualification, and regulatory compliance, along with the ability to lead validation efforts and collaborate with cross-functional teams.
Key Responsibilities
• Lead and execute
Computer System Validation (CSV)
activities across infrastructure and application systems
• Perform
infrastructure qualification
for systems such as Okta, Active Directory, AWS, and dedicated computing environments
• Develop, review, and execute
validation lifecycle documentation
including URS, FS/DS, Risk Assessments, IQ/OQ/PQ, and Validation Summary Reports
• Validate systems such as
RStudio/Posit, Pinnacle 21, SAS
, and similar platforms
• Work with
Veeva Vault Quality
for validation management, test script authoring, and execution
• Support
deviations, investigations, change control, and CAPA processes
• Ensure compliance with
GxP, 21 CFR Part 11, and GAMP 5
guidelines
• Conduct
risk assessments (FMEA)
and ensure data integrity (ALCOA+) principles are followed
• Collaborate with cross-functional teams including QA, IT, Engineering, and Business stakeholders
• Support
audit readiness and regulatory inspections
(FDA, EMA)
• Provide leadership, guidance, and mentorship to junior team members when needed
Required Qualifications
• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related field
• 5+ years of experience in
CSV within regulated (Pharma/Medical Device) environments
• Strong experience in
infrastructure validation and qualification
• Hands-on experience with
validation of applications and cloud-based systems
• Experience with
Veeva Vault Quality (Validation Management module preferred)
• Strong knowledge of
Deviations, CAPA, Change Control processes
• Excellent
documentation, communication, and project management skills
Preferred / Nice to Have Skills
• Experience with
cloud platforms (AWS)
and modern validation approaches
• Knowledge of
data integrity principles (ALCOA+)
• Experience in
audit support and regulatory inspections
• Familiarity with
statistical tools and validation methodologies
• Ability to work in a
fast-paced, cross-functional environment
