Position Summary:

We are seeking an experienced Validation Engineer to help lead the transition to a modernized, risk-based validation strategy. This role will be responsible for implementing Computer Software Assurance (CSA) methodologies, supporting traditional GxP validations, and driving a scalable validation framework for both GxP and non-GxP systems. The ideal candidate will have hands-on experience in risk-based validation practices and a strong understanding of compliance and quality expectations.

Key Responsibilities:

• Lead the development and rollout of a new risk-based validation approach in alignment with CSA principles and regulatory guidelines.
• Define, implement, and maintain validation strategies for both GxP and non-GxP systems.
• Author and review core validation deliverables including Risk Assessments, Validation Plans, Requirements Specifications, Test Protocols (IQ/OQ/PQ), Traceability Matrices, and Validation Summary Reports.
• Apply critical thinking and risk-based decision making to streamline validation activities while maintaining compliance with applicable regulations (21 CFR Part 11, Annex 11, Data Integrity ALCOA+ principles).
• Collaborate with cross-functional teams (IT, QA, Business, Engineering) to ensure risk-based validation practices are integrated into project lifecycles.
• Provide guidance and training to project teams on CSA, GxP, and non-GxP validation requirements.
• Evaluate current validation processes and recommend improvements based on best practices and industry trends.
• Support supplier and system audits to ensure compliance with internal and regulatory standards.
• Track and report on validation project timelines, risks, and status to leadership.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, Information Technology, or a related field.
• 4–8 years of experience in system validation within life sciences, medical device, pharmaceutical, or biotech industries.
• Deep understanding of CSA methodologies, risk-based validation practices, and GAMP 5 guidelines.
• Strong working knowledge of regulatory requirements for GxP systems (21 CFR Part 11, Annex 11).
• Practical experience implementing and validating non-GxP systems in a structured, compliant environment.
• Exceptional organizational, communication, and technical writing skills.
• Experience leading or participating in validation process improvements and change management initiatives.
• Ability to work independently and collaboratively across multiple projects and priorities.
• Solid IT background with a strong understanding of system architecture, software development lifecycles (SDLC), and infrastructure components.
• Experience working closely with IT and development teams to align validation efforts with Agile, Waterfall, or hybrid SDLC methodologies.
• Familiarity with code deployment processes, configuration management, and DevOps practices as they relate to validation and system readiness.

Preferred Skills:

• Experience validating enterprise systems such as LIMS, MES and ERP.
• Familiarity with Agile and DevOps methodologies.
• Experience with validation in SaaS, cloud, and hybrid environments.
• Knowledge of cybersecurity considerations in system validation

Years of Experience

• 4 Years To 8 Years.