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.
Sobre a Cognizant
Cognizant (NASDAQ: CTSH) é uma construtora de IA e fornecedora de serviços de tecnologia, criando a ponte entre o investimento em IA e o valor para as empresas por meio do desenvolvimento de soluções de IA completas para nossos clientes. Nossa profunda experiência em setores, processos e engenharia nos permite incorporar o contexto único de cada organização em sistemas tecnológicos que potencializam a capacidade humana, geram resultados tangíveis e mantêm empresas globais à frente em um mundo em rápida transformação. Saiba mais em cognizant.ai ou @cognizant.
A Cognizant é uma empregadora que investe em equidade. Sua candidatura não será pautada em raça, cor, gênero, sexualidade, credo, origem, deficiência, gravidez ou qualquer outra característica protegida pelas leis brasileiras.
Informações adicionais de emprego
Os candidatos podem ser obrigados a comparecer a entrevistas presenciais ou por videoconferência. Além disso, os candidatos podem ser obrigados a apresentar seu documento de identificação emitido pelo estado ou governo atual durante cada entrevista.
Embora nosso sistema permita a candidatura em todos os idiomas, o(s) idioma(s) e o(s) nível(is) de proficiência exigidos para o trabalho variam. No entanto, é necessário um nível básico de inglês para fins de comunicação em toda a empresa.
A Cognizant é uma empregadora que investe em equidade. Sua candidatura não será pautada em raça, cor, gênero, sexualidade, credo, origem, deficiência, gravidez ou qualquer outra característica protegida pelas leis brasileiras.
Se você tem uma deficiência que requer adaptações razoáveis para procurar uma vaga de emprego ou enviar uma candidatura, envie um e-mail para [email protected] com sua solicitação e informações de contato.
