Validation Engineer - Boston, MA
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 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.
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!
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.
The Validation Engineer is responsible for:
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
1-4 years of experience in a GMP FDA regulated industry, in a validation engineering role REQUIRED
Experience executing temperature mapping validations is prefered.
Experience with sterilization process validation strongly prefered.
BS in Engineering, Computer Science or technical experience
Excellent communication skills
Strong troubleshooting skills
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.