Lab System Validation Engineer (Onsite)

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

Responsibilities

• Develop validation documentation for pharmaceutical equipment, facilities, and computerized systems used in GLP, GMP, and GCP environments.
• Prepare and execute validation deliverables including validation plans, specifications, test protocols, standard operating procedures, URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, and Traceability Matrix.
• Provide a planned approach for the implementation of CSV deliverables, migration due diligence, and coverage of GXP and Non-GXP areas.
• Offer guidance and leadership regarding Regulatory Compliance and Quality Management requirements.
• Ensure CSV artifacts align with and meet regulatory requirements.
• Prepare and execute test protocols (TP, IQ, OQ, PQ, TSR) and Traceability Matrix for testing in QC/R&D Lab systems.
• Participate in regulatory audits and remediation activities.

Requirements

• Experience/exposure to 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 are essential.
• Experience working in the V model, SOP, and SDLC Lifecycle.
• Adaptation of CSA and Module Validation is preferred.
• Experience in testing and knowledge of at least one QC/R&D Lab system is required.
• Knowledge of working in Jira, Service Now, HP ALM, or any automation testing tools.
• Preferred experience in Agile Development.
• Adaptation to AI is preferred.

Pay

The annual salary for this position is between $75,000 and $123,000, depending on experience and other qualifications of the successful candidate.

This position is also eligible for Cognizant’s discretionary annual incentive program, based on performance and subject to the terms of Cognizant’s applicable plans.

Benefits

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