Validation Engineer / CSV Specialist - Pharma & LIMS
About the Role
As a Validation Engineer / Computer System Validation (CSV) Specialist, you will make an impact by supporting validation activities for laboratory, manufacturing, and enterprise systems within regulated pharmaceutical environments. You will be a valued member of the Quality and Compliance team and work collaboratively with Quality Assurance, Validation, IT, Laboratory Operations, Engineering, and business stakeholders to ensure systems and processes meet regulatory requirements and industry standards.
In this role, you will leverage your expertise in computer system validation, pharmaceutical compliance, and LIMS testing to support the successful implementation, qualification, and validation of computerized systems operating in GxP environments.
In This Role, You Will
- Develop, review, and execute validation deliverables for computerized systems, laboratory systems, pharmaceutical equipment, facilities, and enterprise applications operating within regulated environments.
- Prepare and execute validation documentation including Test Plans (TP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Test Summary Reports (TSR), Traceability Matrices, and Functional Risk Assessments (FRA).
- Perform validation and testing activities for SampleManager LIMS applications and associated laboratory workflows.
- Support system implementations, upgrades, enhancements, and change control activities while ensuring compliance with GxP requirements.
- Review business, functional, and technical requirements to ensure appropriate validation coverage and risk-based testing approaches.
- Collaborate with project teams to develop validation strategies, test protocols, standard operating procedures (SOPs), and compliance documentation.
- Participate in defect management, issue resolution, deviation investigations, and corrective action activities.
- Support regulatory inspections and audits by providing validation evidence, documentation, and compliance support.
- Provide guidance on industry best practices and regulatory expectations in highly regulated pharmaceutical environments.
- Support validation activities across laboratory automation, process automation, enterprise applications, and infrastructure systems.
Work Model
We strive to provide flexibility wherever possible. Based on this role's business requirements, this is a remote position open to qualified applicants in Canada. Occasional travel may be required for client meetings, validation activities, workshops, audits, or project-related needs.
Regardless of your working arrangement, we are here to support a healthy work-life balance through our various wellbeing programs.
The working arrangements for this role are accurate as of the date of posting. This may change based on the project you're engaged in, as well as business and client requirements. Rest assured, we will always be clear about role expectations.
What You Need to Have to Be Considered
- Bachelor's degree in Life Sciences, Engineering, Computer Science, Information Technology, Pharmaceutical Sciences, or a related field.
- Experience supporting Computer System Validation (CSV) activities within pharmaceutical, biotechnology, or life sciences environments.
- Hands-on testing and validation experience with SampleManager LIMS.
- Strong understanding of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and GxP regulatory requirements.
- Experience developing and executing validation documentation including IQ, OQ, PQ, TP, TSR, FRA, and Traceability Matrices.
- Experience supporting computerized systems used in GLP, GMP, and GCP environments.
- Strong technical writing and documentation skills.
- Experience working with cross-functional teams in regulated environments.
- Knowledge of validation lifecycle methodologies and risk-based validation approaches.
- Strong communication, analytical, and problem-solving skills.
These Will Help You Stand Out
- Experience supporting pharmaceutical manufacturing, laboratory operations, or quality systems.
- Exposure to regulatory inspections and audits from health authorities and quality organizations.
- Experience with quality and compliance platforms such as Jira, ServiceNow, TrackWise, Veeva, MasterControl, HP ALM, or ValGenesis.
- Experience with automated testing tools and validation automation initiatives.
- Knowledge of laboratory automation, process automation, enterprise systems, and infrastructure validation.
- Experience supporting global validation and compliance programs.
- Understanding of data integrity principles, electronic records, and electronic signatures requirements.
- Experience working in highly regulated pharmaceutical and biotechnology environments.
We're excited to meet people who share our mission and can make an impact in a variety of ways. Don't hesitate to apply, even if you only meet the minimum requirements listed. Think about your transferable experiences and unique skills that make you stand out as someone who can bring new and exciting things to this role.
Salary and Other Compensation
The annual salary for this position is anticipated to be between CAD $110,000 and CAD $140,000, depending on experience, qualifications, geographic location, skills, and other job-related factors.
This position may also be eligible for Cognizant's discretionary annual incentive program, based on performance and subject to the terms of Cognizant's applicable plans.
Benefits
Cognizant offers a comprehensive benefits package designed to support the health, wellbeing, and financial security of our associates and their families, including:
- Medical, dental, vision, and life insurance
- Retirement savings and employer-sponsored benefit programs
- Employee Assistance Program (EAP)
- Paid vacation and company holidays
- Paid parental leave and family support programs
- Professional development, training, and certification opportunities
- Wellness and mental health resources
- Career growth and internal mobility opportunities
Benefits may vary by province and employment status and are subject to change.
Application Deadline
Applications will be accepted until October 23, 2026.
Cognizant reserves the right to close this posting earlier based on application volume, business needs, or hiring timelines.
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.
Additional employment information
Compensation information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.
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, state or local laws.
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.
