Validation Engineer

Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant to our direct client, a global medical device company in Houston, TX 77054. This role will be on-site 4 days/week.

No C2C, Sponsorship or Third Party Staffing

Job Title: Validation Engineer I (Contract)Initial Duration: 18 months

• **Please Note: This position requires validation experience for Medical Devices-Equipment and NOT Validation for Software.

Summary: 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- Bachelors degree in Engineering or scientific discipline required, Masters is a plus