United Pharma Technologies Inc
Validation Engineer
United Pharma Technologies Inc, San Francisco, California, United States, 94199
We are seeking an experienced
Computer System Validation (CSV) Engineer with strong Veeva Vault expertise
to support validation activities within a regulated pharmaceutical environment. The ideal candidate will have hands‑on experience validating GxP systems and working closely with Quality, IT, and Business stakeholders to ensure regulatory compliance.
Key Responsibilities
Perform
CSV activities
for GxP computerized systems in compliance with
FDA, EMA, and global regulatory requirements
Lead and execute
Veeva Vault validation
(QMS, RIM, eTMF, Clinical, or Safety modules)
Develop and review validation deliverables, including:
User Requirements Specifications (URS)
Functional & Design Specifications (FS/DS)
IQ/OQ/PQ protocols and reports
Traceability Matrix (RTM)
Support
SDLC activities
including system implementation, upgrades, patches, and decommissioning
Ensure
data integrity (ALCOA+)
compliance
Support audits and inspections (FDA, internal, and client audits)
Collaborate with Quality Assurance to address deviations, CAPAs, and change controls
Maintain validation documentation within electronic document management systems
Required Qualifications
Bachelor’s degree in
Life Sciences, Engineering, Computer Science, or related field
4+ years of
CSV experience in a regulated pharmaceutical or biotech environment
Hands‑on experience validating Veeva Vault applications
Strong knowledge of
GAMP 5, 21 CFR Part 11, Annex 11
Experience with
cloud/SaaS validation
Excellent documentation, communication, and stakeholder coordination skills
Preferred Qualifications
Experience with
Agile or Waterfall SDLC methodologies
Exposure to other validated systems (LIMS, QMS, ERP, MES)
Prior experience supporting
regulatory inspections
Veeva Vault certification is a plus
Seniority level
Mid‑Senior level
Employment type
Contract
Industries
Pharmaceutical Manufacturing
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Computer System Validation (CSV) Engineer with strong Veeva Vault expertise
to support validation activities within a regulated pharmaceutical environment. The ideal candidate will have hands‑on experience validating GxP systems and working closely with Quality, IT, and Business stakeholders to ensure regulatory compliance.
Key Responsibilities
Perform
CSV activities
for GxP computerized systems in compliance with
FDA, EMA, and global regulatory requirements
Lead and execute
Veeva Vault validation
(QMS, RIM, eTMF, Clinical, or Safety modules)
Develop and review validation deliverables, including:
User Requirements Specifications (URS)
Functional & Design Specifications (FS/DS)
IQ/OQ/PQ protocols and reports
Traceability Matrix (RTM)
Support
SDLC activities
including system implementation, upgrades, patches, and decommissioning
Ensure
data integrity (ALCOA+)
compliance
Support audits and inspections (FDA, internal, and client audits)
Collaborate with Quality Assurance to address deviations, CAPAs, and change controls
Maintain validation documentation within electronic document management systems
Required Qualifications
Bachelor’s degree in
Life Sciences, Engineering, Computer Science, or related field
4+ years of
CSV experience in a regulated pharmaceutical or biotech environment
Hands‑on experience validating Veeva Vault applications
Strong knowledge of
GAMP 5, 21 CFR Part 11, Annex 11
Experience with
cloud/SaaS validation
Excellent documentation, communication, and stakeholder coordination skills
Preferred Qualifications
Experience with
Agile or Waterfall SDLC methodologies
Exposure to other validated systems (LIMS, QMS, ERP, MES)
Prior experience supporting
regulatory inspections
Veeva Vault certification is a plus
Seniority level
Mid‑Senior level
Employment type
Contract
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr