Lab System Validation

TechDigital Group; West Point (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

TechDigital Group is seeking a validation specialist with pharma CSV experience to drive regulatory compliance and documentation for computerized systems in GLP, GMP, and GCP settings.

You will develop URS, IQ/OQ/PQ, and VSR deliverables, contribute to CSA and module validation, and support regulatory audits and remediation activities.

Qualifications

• Experience with CSV validation for pharma equipment, facilities, or systems.
• Knowledge of 21 CFR Part 11, EU Annex 11 and GAMP 5 is required.
• Strong technical writing and communication skills are essential.

Responsibilities

• Develop validation documentation including URS, IQ/OQ/PQ, and VSR artifacts.
• Lead CSV activities in GLP/GMP/GCP environments and coordinate audits.
• Collaborate on CSA/module validation and regulatory compliance tasks.

Skills

CSV Validation

GxP Compliance

Regulatory Standards

Lab Systems Validation

Technical Writing

Documentation

Tools

Jira

ServiceNow

ALM Tools

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.