Lab Computing Support Engineer (Onsite)

Cognizant; California (MO); On-site; USD 75,000 - 123,000; Full time

Benefits offered by this job

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

Job summary

Cognizant is seeking a CSV Validation Specialist to lead validation activities for pharmaceutical systems in GMP/GLP/GCP environments. You will craft validation plans, test protocols, URS/IQ/OQ/PQ, and traceability matrices while ensuring Regulatory compliance and quality management.

Experience with Lab systems and Ag ile practices is preferred. The role emphasizes documentation discipline, strong communication skills, and collaboration across QA, IT, and facilities teams within a US-based

Qualifications

• Experience/exposure to CSV, US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
• Experience of CSV Validation in Lab systems is must.
• Pharmaceutical domain knowledge is must.
• Good communication and technical writing skills are a must.
• Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
• Project Deliverables will include validation plans, specifications, test protocols and SOPs for systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
• CSV, GAMP 5 CPFR Part 11, Validation, V model experience; SOP & SDLC lifecycle familiarity; CSA adaptation preferred.
• Provide guidance and leadership on Regulatory Compliance and Quality Management requirements.

Responsibilities

• Prepare and execute URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix.
• Develop validation artefacts and ensure regulatory alignment.

Skills

CSV exposure

FDA Part 11

EU Annex 11

GAMP 5

Lab systems validation

GLP/GMP/GCP

Regulatory compliance

Agile development

Jira

ServiceNow

HP ALM

Tools

Jira

ServiceNow

HP ALM

Job description

Job Details

• 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.


• Should worked in pharmaceutical domain and its related knowledge is must


• Good communication and technical writing skills are a must


• 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 and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.


• CSV, GAMP 5 CPFR Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle. Adaptation of CSA and Module Validation is preferred.


• To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areas


• Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement.


• Prepare and execute URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix etc.


• Exposure to Regulatory Audits and Remediation activities


• Ensure the CSV artefacts are in line and meets regulatory requirements


• Preferred Experience in Agile Development


• Knowledge on working in Jira / Service Now


• Adaptation to AI is preferred.

Testing (in addition to above)

• 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 is must.


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


• Please note this role is not able to offer visa transfer or sponsorship now or in the future*

Salary And Other Compensation

Applications will be accepted until Sept 04, 2026.

The annual salary for this position is between $ 75,000 - $ 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: Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:

• 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