Lab Systems Validation Consultant

About the role

This position involves developing validation documentation for pharmaceutical equipment, facilities, and computerized systems used in GLP, GMP, and GCP environments. The role requires a planned approach for implementing CSV deliverables, migration due diligence, and addressing both GXP and non-GXP areas.

Responsibilities

• Provide guidance and leadership regarding regulatory compliance and quality management requirements.
• Prepare and execute validation documentation, including URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, and Traceability Matrix.
• Ensure CSV artifacts meet regulatory requirements and are aligned with US FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Support regulatory audits and remediation activities.
• Develop validation plans, specifications, test protocols, and standard operating procedures for systems such as Process Automation, Laboratory Automation, Enterprise IT Applications, and Network Infrastructure.
• Experience in testing and knowledge of QC/R&D Lab systems.
• Prepare and execute test protocols (TP, IQ, OQ, PQ, TSR) and Traceability Matrix.

Requirements

• Experience with Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
• CSV validation experience in at least one Lab system is required.
• Must have worked in the pharmaceutical domain with related knowledge.
• Good communication and technical writing skills.
• Experience working in a V model and familiarity with SOP & SDLC Lifecycle.
• Adaptation of CSA and Module Validation is preferred.
• Preferred experience in Agile Development.
• Knowledge of Jira, Service Now, HP ALM, or other automation testing tools.
• Adaptation to AI is preferred.

*This role is not able to offer visa transfer or sponsorship now or in the future.

Pay

The annual salary for this position is between $75,000 and $123,000, depending on experience and qualifications. This position is also eligible for Cognizant’s discretionary annual incentive program, based on performance.

Benefits

• Medical, Dental, Vision, and Life Insurance.
• Paid holidays plus Paid Time Off.
• 401(k) plan and contributions.
• Long-term and Short-term Disability.
• Paid Parental Leave.
• Employee Stock Purchase Plan.