Validation Engineer -Computer System Validation

Astra North Infoteck Inc.

  • Mississauga, ON
  • Permanent
  • Full-time
  • 2 days ago
Job Title: Validation Engineer (Computer System Validation – Life Sciences)
Location: Mississauga, ON (Onsite)Experience: 8–10+ YearsWe are seeking an experienced Validation Engineer with strong expertise in Computer System Validation (CSV) within the Life Sciences domain. The role involves managing customer deliverables, ensuring timely reporting, and coordinating between onsite stakeholders and offshore teams.
The ideal candidate will have deep experience in CSV lifecycle activities, system validation, regulatory compliance (GxP), and lab systems support.Key Responsibilities
  • Manage customer deliverables and ensure timely reporting
  • Coordinate between customer stakeholders and offshore teams
  • Support Computerized System Validation (CSV) activities across systems
  • Work on CSV lifecycle including planning, execution, and documentation
  • Author and support key System Life Cycle (SLC) and validation deliverables
  • Collaborate with Compliance, QA, and Internal Audit teams for GxP compliance
  • Partner with managed services teams for platform, database, and enhancement support
  • Support system configurations and operational workflows
  • Analyze and translate business requirements into technical/process solutions
  • Document and present complex technical and compliance-related issues
  • Support validation of lab systems including:
  • Sample management
  • Results analysis
  • Lab workflows
  • Release & stability management
  • LES / ELN systems
Essential Skills
  • 8–10+ years of experience in Computer System Validation (CSV)
  • Strong experience in Life Sciences / Pharma / GxP regulated environments
  • Experience with system upgrades, enhancements, and operational support
  • Strong understanding of CSV lifecycle and validation documentation
  • Experience with Lab systems (LIMS, LES, ELN, sample management tools)
  • Ability to analyze complex business processes and translate into solutions
  • Experience working in matrixed, cross-functional global teams
  • Strong stakeholder management and communication skills
  • Strong analytical and problem-solving capabilities
  • Experience supporting compliance, QA, and audit requirements
  • Ability to work independently and lead workstreams
Nice to Have
  • Exposure to lab execution systems and stability/release management tools
  • Experience in regulated pharmaceutical or biotech environments
  • Familiarity with system lifecycle management (SLC) frameworks

Astra North Infoteck Inc.