Validation Engineer I
: Job Details :

Responsibilities:

• Develop and coordinate execution of protocols for equipment (IQ/OQ/PQ) and process validations, prepare final reports following the execution.

• Support evaluation and analysis of data, lead investigation and documentation of all validation deviations and determine impact on the validations.

• Assist in the implementation and maintenance of the Validation Master Plan.

• Review and modify validation strategy and procedures for the validation of the products, processes, and equipment for improved efficiency.

• Oversee protocol development, validation activities, and record tracking in conformance with company policy, current regulatory requirement, and industry standards.

• Provide support for pFMEA, CAPA, and QN efforts as assigned.

• Establish the metrics and monitor the performance of processes, equipment, and tools to verify their efficiency, initiate re-validations and process improvement as needed.

Requirements:

• Excellent oral and written communication, organizational, and teamwork skills are required.

• Proficient in Microsoft Office. (Word, PowerPoint, Excel, etc.)

• Ability to manage multiple tasks with limited supervision.

• Experience with Six Sigma and Lean Manufacturing.

• Experience with Design Verification, Validation Protocol and Report creation, statistical process control (SPC), design of experiments (DOE), Process Control Plans, Sampling methodologies, Data Analysis.

• Master's of Science in Engineering or scientific discipline preferred.