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Validation Engineer

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 still growing to meet the needs of our clients amidst this difficult, changing business environment. Ellab understands the value of people who take true ownership of their responsibilities and how that impacts patient safety. We need people who want to join our team and immerse themselves in our incredible culture.

Do you have at least 1 year experience executing temperature mapping related validation protocols in a GMP environment? 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 Validation Engineer shall perform validation consulting services, including but not limited to process validation and equipment qualification, protocol generation and execution, data analysis and reporting, and calibration.

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 Validation Engineer is to meet all customer expectations while performing field support of customer equipment.

Responsibilities:

  • 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:

  • 1-4 years of experience in a GMP FDA regulated industry, in a validation engineering role REQUIRED
  • Experience executing temperature mapping validations is required
  • BS in Engineering related major or equivalent technical experience.
  • Excellent communication skills.
  • Strong troubleshooting skills.
  • Computer literacy
  • Proficiency with Ellab software is a plus
  • Must be able to lift 50 lbs.

Ellab expresses commitment to promote equality and to conduct our business according to principles of social justice, respect and freedom of expression when dealing with diversity in the workplace. Ellab shall therefore not make any distinction, exclusion or preference on the basis of age, race, color, sex, religion, political opinion, national extraction or social origin.

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

Application

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 11 countries and by more than 40 distributors. With more than 70 years of experience, Ellab has around 370 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 2019 we joined forces with Hanwell Solutions Ltd. in UK in order to expand our product offering to cover industry leading wireless environmental monitoring systems. EQT (www.eqtgroup.com) has acquired the majority ownership in Ellab.

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