System Validation Engineer

About the role

We are seeking an experienced System Validation Engineer to lead validation activities for pharmaceutical and life‑science applications. The role involves ensuring compliance with regulatory standards and supporting multiple IT projects in a dynamic environment.

Key responsibilities

• Develop, review, and approve validation deliverables for enterprise and laboratory applications such as SAP/S4 HANA, Veeva, Trackwise, LIMS, MODA, SCADA, and MES.
• Apply risk‑based testing, requirement traceability, and defect lifecycle management throughout the software development life cycle.
• Conduct periodic control maturity assessments, audits, and ensure adherence to 21 CFR Part 11, GxP, GAMP 5, and other pharmaceutical regulations.
• Support validation of clinical, regulatory, and manufacturing systems, including EDC, CTMS, CDR, and related SaaS/Cloud solutions.

Required profile

• 5‑10 years of professional experience in the Life Sciences industry, preferably within a consulting services organization or industry setting.
• Strong knowledge of pharmaceutical compliance regulations (21 CFR Part 11, GxP, GAMP 5) and quality management processes.
• Proven ability to manage multiple projects and adapt quickly to changing situations in complex environments.

Required skills

• Computerized System Validation / Assurance
• Risk Management and Test Management
• Software Development Life Cycle (SDLC) and testing methodologies
• Enterprise application validation (SAP/S4 HANA, Veeva, Trackwise)
• Laboratory and manufacturing system validation (LIMS, MODA, SCADA, MES)
• Clinical and regulatory application knowledge (EDC, CTMS, CDR)
• Validation tools such as Kneat, ServiceNow, Veeva