Join a forward-thinking organization where your expertise will contribute to the critical validation of processes in a highly regulated environment. You will play a key role in ensuring compliance with industry standards and supporting streamlined operations.

We are looking for a dedicated professional to fill the role of Validation Specialist. The ideal candidate is detail-oriented, possesses a solid understanding of compliance regulations, and is enthusiastic about maintaining high-quality standards.

• You handle the development, implementation, and execution of URS, SIA, DQ, IQ, OQ, PQ, RV, and TM activities.
• You perform validation of systems, utilizing industry precedence and interpreting standards in accordance with cGMP, cGLP’s, and relevant procedures.
• You ensure that the validated status of process systems in scope is continuously compliant with cGMP.
• You support projects following all required regulatory standards.
• You stay informed on emerging validation regulations and practices to meet or exceed cGMP requirements.
• You generate and assist with validation documentation (protocols/reports) using the Kneat paperless validation tool.
• You provide input regarding changes that may impact validated status and documentation.