System Validation, Platform Qualification with Life Sciences Domain
About the role
Role: System Validation, Platform Qualification with Life Sciences Domain Location: Toronto, Canada Hybrid Domain: Life Sciences, Pharma and Biotech Please share the resume at aravind@burgeonits.com
Role Overview We are looking for a highly experienced Validation resource with 10+ years of experience in Computerized System Validation (CSV) within the Life Sciences domain. The candidate will lead end-to-end validation activities for enterprise-level software systems and manage teams, stakeholders, and delivery for global programs. Key Responsibilities Lead end-to-end validation lifecycle (Planning, Risk Assessment, Testing, Release, Periodic Review) Drive validation strategy for enterprise programs across regions (Europe/Global) Manage validation teams, allocate work, and ensure timely delivery Act as primary point of contact for client stakeholders and leadership Lead governance, status reporting, and escalation management Author and review validation deliverables (URS, FRS, IQ/OQ/PQ, RTM, Validation Report) Ensure compliance with 21 CFR Part 11, EU Annex 11, Data Integrity (ALCOA+) Manage quality processes (Deviation, CAPA, Change Control) Support regulatory audits and inspection readiness Mentor and coach junior resources, build capability within the team Drive continuous improvement and standardization of validation processes Managerial Skills Team leadership and people management Stakeholder and client relationship management Program and project management for global validation initiatives Risk and issue management with mitigation planning Resource planning and capacity management Governance, reporting, and executive communication Budget awareness and delivery management Cross-functional coordination across IT, QA, Business and Vendors Required Skills & Competencies 10+ years of experience in Life Sciences CSV/CSA Exposure to cloud/SaaS validation Strong experience in enterprise systems (SAP S/4HANA, Veeva Vault, LIMS, QMS etc.) understanding of SDLC and validation lifecycle Understanding on regulatory guidelines (GAMP 5, GxP, 21 CFR Part 11, EU Annex 11 etc.) Experience in risk-based validation and CSA approach Experience working with US and European clients and regulated environments Strong documentation, communication, and leadership skills
Not the right fit? Search for System Validation, Platform Qualification with Life Sciences Domain jobs in Toronto, Ontario, Canada
About BURGEON IT SERVICES
Burgeon is a provider of technical and IT staff augmentation solutions. We are in business to help you maintain your competitive advantage by cost-effectively delivering highly skilled consultants when and how you need them most.
Burgeon is located in USA, AUSTRALIA & INDIA.
Burgeon offers Contract, Contract-to-Hire, Direct Hire and Payroll Services to companies of all sizes.
Burgeon understands the reaction time required to consistently provide companies with the technical resources necessary for growth. Burgeon places heavy emphasis on internal hiring, database technology integration, ongoing internal training and customer service. Our goal is to build a working relationship with you that is mutually beneficial. As a result, we are highly motivated to consistently deliver the best consultants and the best customer service available.
Burgeon has earned a reputation amongst companies and consultants as being fair dealing and highly customer service oriented. We invite you to experience the difference working with Burgeon can make.
Our Culture
Burgeon has a unique culture and a very distinct, progressive, and professional attitude. We are results driven and passionate about matching the right people with the right companies. We take pride in providing quality consultants to reputable clients in order to ensure a mutually beneficial relationship. We fully understand the competitiveness of our business and rely on each other to maintain an adaptable, professional atmosphere. Our employees work in a fast-paced environment focused on goal setting and accomplishing those goals.
Vision
To provide the highest quality IT resources for small, medium, and Fortune 500 companies.
Mission
At Burgeon we are passionate about matching great people with great companies.
Values
Achieving our mission requires intelligent, energetic and committed people who possess:
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System Validation, Platform Qualification with Life Sciences Domain
About the role
Role: System Validation, Platform Qualification with Life Sciences Domain Location: Toronto, Canada Hybrid Domain: Life Sciences, Pharma and Biotech Please share the resume at aravind@burgeonits.com
Role Overview We are looking for a highly experienced Validation resource with 10+ years of experience in Computerized System Validation (CSV) within the Life Sciences domain. The candidate will lead end-to-end validation activities for enterprise-level software systems and manage teams, stakeholders, and delivery for global programs. Key Responsibilities Lead end-to-end validation lifecycle (Planning, Risk Assessment, Testing, Release, Periodic Review) Drive validation strategy for enterprise programs across regions (Europe/Global) Manage validation teams, allocate work, and ensure timely delivery Act as primary point of contact for client stakeholders and leadership Lead governance, status reporting, and escalation management Author and review validation deliverables (URS, FRS, IQ/OQ/PQ, RTM, Validation Report) Ensure compliance with 21 CFR Part 11, EU Annex 11, Data Integrity (ALCOA+) Manage quality processes (Deviation, CAPA, Change Control) Support regulatory audits and inspection readiness Mentor and coach junior resources, build capability within the team Drive continuous improvement and standardization of validation processes Managerial Skills Team leadership and people management Stakeholder and client relationship management Program and project management for global validation initiatives Risk and issue management with mitigation planning Resource planning and capacity management Governance, reporting, and executive communication Budget awareness and delivery management Cross-functional coordination across IT, QA, Business and Vendors Required Skills & Competencies 10+ years of experience in Life Sciences CSV/CSA Exposure to cloud/SaaS validation Strong experience in enterprise systems (SAP S/4HANA, Veeva Vault, LIMS, QMS etc.) understanding of SDLC and validation lifecycle Understanding on regulatory guidelines (GAMP 5, GxP, 21 CFR Part 11, EU Annex 11 etc.) Experience in risk-based validation and CSA approach Experience working with US and European clients and regulated environments Strong documentation, communication, and leadership skills
Not the right fit? Search for System Validation, Platform Qualification with Life Sciences Domain jobs in Toronto, Ontario, Canada
About BURGEON IT SERVICES
Burgeon is a provider of technical and IT staff augmentation solutions. We are in business to help you maintain your competitive advantage by cost-effectively delivering highly skilled consultants when and how you need them most.
Burgeon is located in USA, AUSTRALIA & INDIA.
Burgeon offers Contract, Contract-to-Hire, Direct Hire and Payroll Services to companies of all sizes.
Burgeon understands the reaction time required to consistently provide companies with the technical resources necessary for growth. Burgeon places heavy emphasis on internal hiring, database technology integration, ongoing internal training and customer service. Our goal is to build a working relationship with you that is mutually beneficial. As a result, we are highly motivated to consistently deliver the best consultants and the best customer service available.
Burgeon has earned a reputation amongst companies and consultants as being fair dealing and highly customer service oriented. We invite you to experience the difference working with Burgeon can make.
Our Culture
Burgeon has a unique culture and a very distinct, progressive, and professional attitude. We are results driven and passionate about matching the right people with the right companies. We take pride in providing quality consultants to reputable clients in order to ensure a mutually beneficial relationship. We fully understand the competitiveness of our business and rely on each other to maintain an adaptable, professional atmosphere. Our employees work in a fast-paced environment focused on goal setting and accomplishing those goals.
Vision
To provide the highest quality IT resources for small, medium, and Fortune 500 companies.
Mission
At Burgeon we are passionate about matching great people with great companies.
Values
Achieving our mission requires intelligent, energetic and committed people who possess: