**Senior Validation Engineer Position Summary
Key Responsibilities
* Develop and execute qualification and validation strategies for life cycle approach, adhering to regulatory requirements and company procedures.
* Author, review, and approve testing protocols and reports. Participate in project delivery, vendor interactions, and troubleshooting of process systems.
* Maintain a validated state by performing duties in accordance with Good Manufacturing Practices (GMP) requirements, standard operating procedures (SOPs), and controlled documents.
Required Qualifications and Experience
* A minimum of 3-5 years' experience working in a pharmaceutical or similar GMP environment as part of a validation, MSAT, or engineering function.
* Experience in commissioning and qualification/validation of facilities, utilities, equipment, and instruments (e.g., bioreactors, chromatography, ultrafiltration, autoclaves, parts washers).
* Knowledge of maintaining the validated state through requalification/revalidation of critical utility systems (CTUs), cleanrooms, and clean equipment.
* Ability to troubleshoot and provide technical solutions for GMP manufacturing operations and equipment in a biologics processing environment.
* Experience with equipment vendor package ownership and system design coordination.