Key Responsibilities
1. OT GxP Validation
- Lead GxP validation activities associated with changes to OT systems, applications and infrastructure.
- Perform/review GxP impact and risk assessments for proposed OT changes.
- Define the appropriate risk-based validation approach based on system criticality and GxP impact.
- Ensure validation requirements are incorporated into OT remediation, migration and cutover plans.
2. Validation Documentation & Execution
- Prepare, review and update validation documentation using Client approved SOPs and templates.
- Develop/review IQ and OQ protocols, test scripts and associated evidence.
- Coordinate execution of qualification/validation tests during OT infrastructure and application changes.
3. OT Infrastructure & Application Changes
Provide validation oversight for GxP-impacting changes involving areas such as:
- OT application servers and virtual machines
- OT network and infrastructure changes
- OT Active Directory/domain-related changes
- Application interfaces and integrations
4. Migration & Cutover Validation
- Review migration and cutover plans from a GxP validation perspective.
- Ensure required validation activities are included within migration runbooks.
- Verify execution of required IQ/OQ and interface testing.
Required Skills & Experience
- Strong experience in GxP validation / Computer System Validation (CSV) within regulated manufacturing environments.
- Experience validating Operational Technology (OT) systems and infrastructure.
- Strong understanding of GAMP 5 and risk-based validation principles.
- Good understanding of manufacturing OT architecture and IT/OT dependencies.
- Ability to work with QA, Engineering, IT/OT, infrastructure, cybersecurity, application SMEs and OEM/vendor teams.
- Strong documentation, stakeholder-management and communication skills.
Preferred OT Knowledge
For this position, I would specifically look for candidates who have worked around technologies such as:
- SCADA / HMI
- MES / manufacturing applications
- PLC/DCS-connected applications
- OPC / industrial communication interfaces
- Industrial networks and firewalls
- OT Active Directory
Things to know before you apply
- Work authorization: Cognizant will only consider applicants for this position who are legally authorized to work in Canada without requiring employer sponsorship, now or at any time in the future.
- Accommodations: If you have a disability that requires reasonable accommodation to search for a job opening or submit an application, please email [email protected] with your request and contact information.
- AI in hiring: We use artificial intelligence (AI) tools to help us screen and assess applications more efficiently. Our team performs additional human review and ultimately decides who moves forward in our hiring process.
- Open position: Unless otherwise stated, this job posting is for an open position on our team.
- Language proficiency: We ask that all candidates have basic English proficiency for company-wide communications purposes. For roles based in Quebec, professional English proficiency is required, as you’ll deliver services to and collaborate with stakeholders outside the province who may not speak French.
- Inclusion: Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, provincial or local laws.
About Cognizant
Cognizant (Nasdaq: CTSH) is an AI Builder and technology services provider, bridging the gap between AI investment and enterprise value by building full-stack AI solutions for our clients. Our deep industry, process and engineering expertise enables us to build an organization’s unique context into technology systems that amplify human potential, drive tangible outcomes and keep global enterprises ahead in a fast-changing world. See how at cognizant.ai or @cognizant.
