Validation Engineer​/CSV Specialist - Pharma & Lims

Validation Engineer / CSV Specialist - Pharma & LIMSAbout 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.

• 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 Sample Manager 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.

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.

• 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 Sample Manager 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…