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Validation Engineer - Greater Boston Area

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 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:

The Validation Engineer is responsible for:

  • 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
  • 0 to 5 years of experience in an FDA regulated industry, preferably in an engineering, validation or operations role
  • Excellent communication skills
  • Strong troubleshooting skills
  • Computer literacy, including proficiency with Ellab software applications
  • Must be able to lift 50 lbs

Ellab offers:

  • Exciting technical challenges with personal growth opportunities
  • A work environment that facilitates innovation and inspiration
  • Exposure to many different organizations and locations
  • Competitive salary and benefits package

For more information about the job please contact VP, Business Development 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 7 countries and by more than 40 distributors. With more than 69 years of experience, Ellab has around 170 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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