Senior Validation Engineer

Immatics N.V - Houston, TX

Full-time - Senior

Houston, TX

About the position

The Senior Validation Engineer will lead the implementation of an ERP System, specifically SAP S4 Hana, through functional configuration to deployment. This role involves writing and executing all validation deliverables while collaborating with internal stakeholders and external partners to ensure the system meets company needs. The position requires expertise in validation processes within a GxP regulated environment, particularly in the pharmaceutical or biotech industry.

Responsibilities

• Lead the implementation of SAP S4 Hana through functional configuration to deployment.
• Support functional configuration and implementation of SAP S4 Hana with external partners.
• Create process flow maps to capture defined and undefined processes.
• Act as the representative to ensure end-user needs are met by the system.
• Facilitate integration with software platforms such as LIMS, MES, HR/Payroll, CMMS, and eQMS.
• Draft validation documents including validation plans, URS, risk assessments, and qualification protocols.
• Execute test scripts from IQ/OQ/PQ protocols and provide supporting evidence.
• Create and manage project timelines and deliverables.
• Assess new software updates and perform necessary validation activities.
• Monitor and review Quality Management Systems to ensure compliance with requirements.
• Contribute to writing and approval of Quality Events as needed.
• Coordinate and investigate CAPAs.
• Draft SOPs and work instructions for system operation and maintenance.
• Assist in Change Control processes and training.
• Support cross-functional groups for QMS functions and projects.

Requirements

• Bachelor's Degree in Science, Engineering, or a related major; education in Biotechnology preferred.
• 5-7 years of experience in SAP implementation projects.
• Experience in the pharmaceutical/biotechnology industry is preferred.
• Experience with SAP Solution Manager for Change Control.
• Understanding of good documentation practices and data integrity principles.
• Familiarity with 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211, GAMP 5, and USP.

Nice-to-haves

• Experience working within a GxP regulated manufacturing or laboratory environment.
• Ability to make sound decisions and approach problems with curiosity and open-mindedness.
• High degree of independent working and analytical reasoning.

Benefits

• Equal opportunity employer with a commitment to diversity and inclusion.