Lab System Validation

Katalyst CRO; Rahway (NJ); Sur place; USD 110 000 - 150 000; Plein temps

Résumé du poste

Katalyst CRO seeks a skilled CSV Validation professional to drive validation of laboratory and enterprise systems in a GMP/GCP setting. You will develop and execute validation deliverables across equipment, facilities and computerized systems, aligning with CSA, SDLC and V-model practices.

Ideal candidates have pharma domain expertise, strong technical writing, and familiarity with regulatory standards such as 21 CFR Part 11 and Annex 11. Collaboration with QA, IT, and Lab teams is essential.

Qualifications

• Experience with CSV Validation in Lab systems and GAMP 5 guidance.
• US FDA 21 CFR Part 11, EU Annex 11 familiarity is required.
• Must have pharmaceutical domain knowledge and related regulatory exposure.
• Strong technical writing and validation documentation skills.

Responsabilités

• Develop validation documentation for pharmaceutical equipment, facilities and computerized systems in GLP, GMP and GCP environments.
• Prepare and execute URS, MVP, VP, RTM, IQ, OQ, PQ, VSR and Traceability Matrix artifacts.
• Lead CSV validation efforts, provide guidance on compliance and quality management.
• Deliver validation plans, specifications, test protocols and SOPs; work with QA, IT and Lab teams.
• Support regulatory audits and remediation activities; ensure artefacts meet regulatory requirements.

Connaissances

CSV validation

Pharma domain knowledge

Regulatory compliance

Technical writing

Agile development

Outils

Jira

ServiceNow

Client ALM

Description du poste

• Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
• Experience of CSV Validation in any one of the Lab systems is must.
• Should worked in pharmaceutical domain and its related knowledge is must
• Good communication and technical writing skills are a must
• Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
• Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
• CSV, GAMP 5 CPFR Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle. Adaptation of CSA and Module Validation is preferred.
• To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areas
• Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement.
• Prepare and execute URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix etc.
• Exposure to Regulatory Audits and Remediation activities
• Ensure the CSV artefacts are in line and meets regulatory requirements
• Preferred Experience in Agile Development
• Knowledge on working in Jira / Service Now
• Adaptation to AI is preferred.
• Testing (in addition to above)
• Experience in testing and knowledge in any one of the QC/R&D Lab systems is must.
• Prepare and execute TP, IQ, OQ, PQ, TSR, Traceability Matrix etc is must.
• Knowledge on working in Jira, Client ALM or any automation testing tools.