CSV and Validation Engineer

Katalyst-Healthcares-; Jersey City (NJ); Vor Ort; USD 100.000 - 140.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

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

Tools

LIMS

ELN

CDS

Instrument control software

ALM/Jira/Xray

ValGenesis

Veeva

MasterControl

TrackWise

Jobbeschreibung

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.