Audit-Ready CSV & Validation Engineer for Lab Systems

Creative Solutions Services, LLC

Jersey City (NJ)

On-site

USD 100,000 - 140,000

Full time

3 days ago

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Job summary

Creative Solutions Services, LLC seeks 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 include planning and executing computer system validation, authoring validation artifacts, ensuring

Qualifications

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.

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.