Validation Engineer - #1126906

Job scope:

• Contributes to validation planning and assists with carrying out medium- to large-scale projects that require customized, risk-based execution strategies, problem investigations, and troubleshooting while meeting project timelines.

• Utilizes expertise and input from Subject Matter Experts to perform effective risk assessments and develop experimental designs for project tasks.

• Prepares, executes, and evaluates validation protocols and associated documentation in alignment with company policies and procedures, including (but not limited to) FMEA, URS, PVP.

• Serves as the main validation representative for the project team, acting as the primary point of contact for validation-related aspects of contracts and projects.

• Engages with internal stakeholders and external partners on significant validation issues that may require cross-organizational coordination.

• Collaborates with technical support teams to perform qualification tests and engineering studies.

• Adheres to all applicable regulations and standards related to Quality, Environmental, Health, Safety, and Energy (EHS&E) Global Policies, Engineering Standards, and other relevant governance requirements.

Requirements:

• Validation expertise in pharmaceutical plant and managing DQ documentation URS/FMEA/PVP