Lab System Validation

TechDigital Group; Rahway (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

TechDigital Group seeks a technically adept validation professional in Rahway, NJ, to drive CSV program execution across laboratory and enterprise systems within GLP, GMP, and GCP contexts.

The role requires hands-on experience with CSV validation in lab environments, familiarity with FDA Part 11 and EU Annex 11, plus strong technical writing and cross-functional communication skills. Agile exposure and Jira/ServiceNow usage are advantages.

Qualifications

• Experience in CSV validation for lab systems in pharma or related domains.
• Familiarity with regulatory frameworks like 21 CFR Part 11 and GAMP 5.
• Strong technical writing and communication abilities.
• Ability to prepare validation artifacts such as URS, IQ/OQ/PQ, VSR, and traceability matrices.

Responsibilities

• Develop validation documentation for pharmaceutical equipment, facilities and computerized systems in GLP, GMP and GCP environments.
• Produce validation plans, specifications, test protocols and SOPs for processes including Process/Lab Automation and Enterprise IT.
• Provide guidance on Regulatory Compliance and Quality Management requirements.

Skills

CSV validation

GAMP 5

FDA Part 11 (US)

EU Annex 11

Pharmaceutical domain knowledge

Lab systems validation

Technical writing

Communication skills

Regulatory compliance

Agile development

Jira

ServiceNow

AI awareness

Tools

Jira

ServiceNow

ALM

Job description

JD:

• o Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
• o Experience of CSV Validation in any one of the Lab systems is must.
• o Should worked in pharmaceutical domain and its related knowledge is must
• o Good communication and technical writing skills are a must
• o Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
• o 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.
• o CSV, GAMP 5 CPFR Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle. Adaptation of CSA and Module Validation is preferred.
• o To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areas
• o Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement.
• o Prepare and execute URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix etc.
• o Exposure to Regulatory Audits and Remediation activities
• o Ensure the CSV artefacts are in line and meets regulatory requirements
• o Preferred Experience in Agile Development
• o Knowledge on working in Jira / Service Now
• o Adaptation to AI is preferred.

Testing (in addition to above)

• o Experience in testing and knowledge in any one of the QC/R&D Lab systems is must.
• o Prepare and execute TP, IQ, OQ, PQ, TSR, Traceability Matrix etc is must.
• o Knowledge on working in Jira, Client ALM or any automation testing tools.