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Sr. Validation Engineer - College Station Texas

Ellab is a leading international supplier of high quality, precision measuring equipment and software for data analysis is used for validation and documentation of thermal processes in life science and medical device industries. Ellab also supplies validation services that support development and manufacturing organizations throughout the lifecycle of a product.

Ellab is growing fast and we need people who want to join our team and immerse themselves in our incredible culture. Ellab understands the value of people who take true ownership of their responsibilities and how that impacts patient safety. Are you ready to join a team of elite validation engineers who set the standard for customer service?  Do you want to work with the finest validation test instruments available?  Well apply today, we're looking forward to meeting you and seeing what you have to offer!

Job brief:

The Sr. Validation Engineer shall perform validation consulting services, including but not limited to process validation and equipment qualification, protocol generation and execution, data analysis and execution, data analysis and reporting, and calibration. The role will involve some local business development as well as new hire training.

The position will primarily work during normal business hours of 8 AM to 5 PM, Monday through Friday, but may require occasional off-hours and weekend work, and travel.

The goal of the Sr. Validation Engineer is to meet all customer expectations while performing field support of customer equipment.

Responsibilities:

  • Assist in quoting of validation projects
  • Assist in managing delivery of validation projects
  • Author, review, approve and execute validation documentation including protocols, summary reports, procedures, other lifecycle documents.
  • Performing calibrations and verifications in support of validation and engineering projects.
  • Interfacing with customers to develop validation documentation, schedule projects, and communicate study results.
  • Recording and reconciling project costs and information required for final billing.
  • Analyze and interpret data from qualification studies if it meets acceptance criteria.
  • Troubleshooting customer and Ellab equipment.
  • Support and maintain the validation department equipment inventory.

Requirements:

  • BS in Engineering, Computer Science or technical experience
  • 4+ years of experience in an FDA regulated industry, in a validation engineering role
  • Experience writing and executing temperature mapping validation protocol on CTU's and Sterilization equipment is required.
  • Experience in a supervisory or management role is a plus
  • Excellent communication skills.
  • Strong troubleshooting skills.
  • Computer literacy, including proficiency with Ellab software applications.
  • Must be able to lift 50 lbs.

For more information about the job please contact Director of Human Resources at Ellab Inc. Erik Zotter at 303-425-3370.

Application:
Please apply for the job via LinkedIn here.

About Ellab:
Ellab is an international company with manufacturing, research and development facilities in Denmark. Our Validation Solutions are sold and supported through Ellab sales and service companies in 8 countries and by more than 40 distributors. With more than 70 years of experience, Ellab has around 260 dedicated employees worldwide. Ellab improves the quality of life by contributing to building confidence in the food, pharmaceutical and medical device industries by providing solutions for recording, monitoring and validating critical parameters of thermal processing procedures. In 2016 Ellab A/S and subsidiaries were sold to IK VIII Fund managed by IK Investment Partners.

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