United Pharma Technologies Inc
We are seeking a Validation Engineer with 4+ years of experience in the pharmaceutical industry and strong expertise in
Veeva Vault . The candidate will be responsible for validating GxP systems, ensuring compliance with regulatory requirements, and supporting quality and compliance initiatives.
Key Responsibilities
Perform computer system validation (CSV) for Veeva Vault applications (QMS, eTMF, RIM, QualityDocs, etc.)
Develop and execute validation deliverables: URS, FS, IQ, OQ, PQ, RTM
Ensure compliance with FDA 21 CFR Part 11, GAMP 5, and global GxP regulations
Support system implementation, upgrades, and periodic reviews
Conduct risk assessments and validation impact assessments
Collaborate with QA, IT, and business stakeholders
Support audits and inspections (FDA, internal, and client audits)
Required Skills & Qualifications
4+ years of experience as a Validation/CSV Engineer in pharma or life sciences
Hands‑on experience with Veeva Vault validation
Strong knowledge of GxP, Part 11, and data integrity requirements
Experience with SOPs, change control, deviation, and CAPA processes
Excellent documentation and communication skills
Seniority Level
Mid‑Senior level
Employment Type
Contract
Job Function & Industries
Pharmaceutical Manufacturing and Medical Equipment Manufacturing
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Veeva Vault . The candidate will be responsible for validating GxP systems, ensuring compliance with regulatory requirements, and supporting quality and compliance initiatives.
Key Responsibilities
Perform computer system validation (CSV) for Veeva Vault applications (QMS, eTMF, RIM, QualityDocs, etc.)
Develop and execute validation deliverables: URS, FS, IQ, OQ, PQ, RTM
Ensure compliance with FDA 21 CFR Part 11, GAMP 5, and global GxP regulations
Support system implementation, upgrades, and periodic reviews
Conduct risk assessments and validation impact assessments
Collaborate with QA, IT, and business stakeholders
Support audits and inspections (FDA, internal, and client audits)
Required Skills & Qualifications
4+ years of experience as a Validation/CSV Engineer in pharma or life sciences
Hands‑on experience with Veeva Vault validation
Strong knowledge of GxP, Part 11, and data integrity requirements
Experience with SOPs, change control, deviation, and CAPA processes
Excellent documentation and communication skills
Seniority Level
Mid‑Senior level
Employment Type
Contract
Job Function & Industries
Pharmaceutical Manufacturing and Medical Equipment Manufacturing
#J-18808-Ljbffr