Overview

The Instrument/Equipment Validation Specialist helps document and validate laboratory instrument software to meet EMA and GxP guidelines. The role ensures that all instrument systems are properly tested, documented, and compliant with PPD IT standards.

Main Responsibilities

• Document and validate lab instrument software.
• Write requirements, test cases, and validation reports.
• Create system and data flow diagrams.
• Perform risk assessments for software and instruments.
• Work with lab, IT, and QA teams to ensure compliance.

Skills Required

• Experience in software or instrument validation in a regulated environment.
• Strong technical writing and documentation skills.
• Knowledge of GxP, EMA, or FDA guidelines.
• Good communication skills and attention to detail.

Preferred

• Familiarity with LIMS, CDS, or other lab software systems.

Understanding of 21 CFR Part 11 and Annex 11 compliance.

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 the Canada. Regardless of your working arrangement, we are here to support a healthy work-life balance though our various wellbeing programs.

Note: 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.

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.

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.