Lab System Validation Engineer - W2 Only

Job Summary

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. Experience in CSV Validation in any one of the Lab systems is required.

Responsibilities

• Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
• Prepare and execute URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix etc.
• Provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areas.
• Guide and lead regarding Regulatory Compliance and Quality Management requirements.
• Exposure to Regulatory Audits and Remediation activities.
• Ensure the CSV artefacts are in line and meet regulatory requirements.
• Experience in Agile Development, Knowledge on working in Jira / Service Now, Adaptation to AI is preferred.
• 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.
• Knowledge on working in Jira, HP ALM or any automation testing tools.

Requirements

• 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.
• Worked in pharmaceutical domain and its related knowledge is must.
• Good communication and technical writing skills are a must.

Qualifications

• Preferable Experience in Agile Development.
• Knowledge on working in Jira / Service Now.
• Adaptation to AI is preferred.

Skills

• Knowledge on working in Jira, HP ALM or any automation testing tools.

Benefits

N/A

Pay

N/A

Schedule

N/A