Validation Engineer - Houston, United States - Astrix Inc

Description

A leader in global healthcare, with a mission to help people live life more fully at each stage Our life-changing technologies span the spectrum of healthcare, ranging from medical devices to branded generic medications, and are utilized in 160 countries.

If you are interested in joining a leader in the industry, apply today

Validation Engineer I
Targeting 1-2 years of experience
1 year+ contract
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.

• 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.

Masters of Science in Engineering or scientific discipline preferred.

This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you

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