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
