Job Description
We are seeking a
Computer System Validation (CSV) Engineer
that is able to join our pharmaceutical operations team
Mid May 2026 .
Key Responsibilities
Manage the full CSV lifecycle
(planning, design, testing, execution, reporting, and closure) for standalone systems such as LIMS, chromatography data systems, environmental monitoring software, and equipment control systems.
Develop and execute validation documentation
including User Requirement Specifications (URS), Functional Specifications (FS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Perform risk assessments
to determine validation scope and ensure compliance with
GAMP 5, 21 CFR Part 11, EU Annex 11 , and other relevant guidelines.
Collaborate with QA, IT, and system owners
to ensure proper change management, deviation handling, and system release.
Support audits and inspections
by regulatory authoritie...
Computer System Validation (CSV) Engineer
that is able to join our pharmaceutical operations team
Mid May 2026 .
Key Responsibilities
Manage the full CSV lifecycle
(planning, design, testing, execution, reporting, and closure) for standalone systems such as LIMS, chromatography data systems, environmental monitoring software, and equipment control systems.
Develop and execute validation documentation
including User Requirement Specifications (URS), Functional Specifications (FS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Perform risk assessments
to determine validation scope and ensure compliance with
GAMP 5, 21 CFR Part 11, EU Annex 11 , and other relevant guidelines.
Collaborate with QA, IT, and system owners
to ensure proper change management, deviation handling, and system release.
Support audits and inspections
by regulatory authoritie...