Overview
Remote
On Site
Full Time
Skills
Informatics
Documentation
Test Plans
Data-flow Diagrams
Backup
Recovery
Auditing
Traceability Matrix
Management
Corrective And Preventive Action
Change Control
Training
Collaboration
Quality Assurance
Computerized System Validation
Life Sciences
Data Integrity
GAMP
URS
FRS
DirectShow
DS
RTM
IQ
OQ
PQ
LIMS
ELN
Middleware
Application Lifecycle Management
JIRA
Veeva
Master Control
Trackwise
Technical Writing
Communication
Job Details
Job Description:
We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs.
Responsibilities:
We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs.
Responsibilities:
- Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5.
- Validate instrument software and lab systems; author URS, FRS, DS, test plans, IQ/OQ/PQ, traceability, and validation summary reports.
- Design and maintain infrastructure and data flow diagrams covering integrations, security, backup/restore, and audit trails.
- Capture business and technical requirements; maintain a bidirectional requirements traceability matrix.
- Execute test cycles, log defects, drive remediation, manage deviations/CAPA, and support inspections.
- Ensure change control, periodic review, training effectiveness, and release readiness for validated systems.
- Collaborate across QA/CSV, IT, and Lab teams; provide clear communication and stakeholder updates.
- 5 to 10+ years in CSV/validation within regulated labs or life sciences.
- Strong knowledge of EMA Annex 11, 21 CFR Part 11, data integrity (ALCOA+), and GAMP 5.
- Proven authorship of URS/FRS/DS, RTM, IQ/OQ/PQ, and validation summary reports.
- Experience with LIMS, ELN, CDS, or instrument control software; familiarity with instrument integrations and middleware.
- Proficiency with test and quality tools such as Client ALM/Jira/Xray, ValGenesis, Veeva, MasterControl, or TrackWise.
- Excellent technical writing, organization, and cross- functional communication.
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