Validation Engineer Computer System Validation
Job Location:
Monthly Salary:
Experience Required:
Posted on:
30+ days ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Job Title: Validation Engineer (Computer System Validation Life Sciences)
Location: Mississauga ON (Onsite)
Experience: 810 Years
We 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
- 810 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
Required Skills:
60-70
Required Education:
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