Fusion Life Sciences
Job Title: CSV Engineer
Location: San Francisco Bay Area, CA (Onsite 4 days/week)
Experience: 5 years
Job Description (Short JD)
Lead Computer System Validation (CSV) activities for
Medidata CTMS
and other clinical applications.
Author and execute validation deliverables including URS, FRS, Risk Assessments, Validation Plan, IQ/OQ/PQ scripts, Traceability Matrix, and Summary Reports.
Ensure compliance with
21 CFR Part 11, GAMP 5, GxP , and internal QA procedures.
Work independently with cross-functional teams (Clinical Operations, QA, IT, Vendors) to manage multiple validation projects.
Perform impact assessments, system configuration reviews, and change control documentation.
Support inspections and audits by providing validation evidence and documentation.
Hands‑on execution of validation scripts and documentation of objective evidence.
Provide SME‑level guidance for clinical systems validation and support lifecycle activities.
Top Skills Required (Short)
Strong CSV expertise
Medidata CTMS validation experience (must-have)
IQ/OQ/PQ authoring & execution
GAMP5, 21 CFR Part 11, GxP compliance
#J-18808-Ljbffr
Location: San Francisco Bay Area, CA (Onsite 4 days/week)
Experience: 5 years
Job Description (Short JD)
Lead Computer System Validation (CSV) activities for
Medidata CTMS
and other clinical applications.
Author and execute validation deliverables including URS, FRS, Risk Assessments, Validation Plan, IQ/OQ/PQ scripts, Traceability Matrix, and Summary Reports.
Ensure compliance with
21 CFR Part 11, GAMP 5, GxP , and internal QA procedures.
Work independently with cross-functional teams (Clinical Operations, QA, IT, Vendors) to manage multiple validation projects.
Perform impact assessments, system configuration reviews, and change control documentation.
Support inspections and audits by providing validation evidence and documentation.
Hands‑on execution of validation scripts and documentation of objective evidence.
Provide SME‑level guidance for clinical systems validation and support lifecycle activities.
Top Skills Required (Short)
Strong CSV expertise
Medidata CTMS validation experience (must-have)
IQ/OQ/PQ authoring & execution
GAMP5, 21 CFR Part 11, GxP compliance
#J-18808-Ljbffr