Audit-Ready CSV & Validation Engineer for Lab Systems

Katalyst-Healthcares-; Jersey City (NJ); Presencial; USD 100.000 - 140.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

CSV/Validation

Regulated labs

EMA Annex 11

21 CFR Part 11

GAMP 5

URS/FRS/DS

IQ/OQ/PQ

RTM

LIMS

ELN

CDS

Instrument integration

ALM/Jira/Xray

ValGenesis

Veeva

MasterControl

TrackWise

Technical writing

Cross-functional communication

Herramientas

LIMS

ELN

CDS

Instrument control software

ALM/Jira/Xray

ValGenesis

Veeva

MasterControl

TrackWise

Descripción del empleo

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:

• 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.
• Requirements:
• 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.