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Validation Engineer

Do you have at least 1 year experience executing validation protocols in a GMP environment?

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.

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 preffered.
  • BS in Engineering, Computer Science 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.

Benefits:

  • Medical Insurance
  • Vision Insurance
  • Dental Insurance
  • 401(k)
  • Paid Maternity Leave
  • Paid Paternity Leave
  • Disability Insurance

Seniority Level
Associate

Industry
Electrical & Electronic Manufacturing Pharmaceuticals Biotechnology

Employment Type
Full-time

Application

Application:
Please apply for the job via LinkedIn here.

 

About Ellab:
Ellab has been your validation and monitoring partner since 1949, offering wireless data loggers and thermocouple systems for thermal validation processes as well as wireless environmental monitoring solutions.

We serve both small and large companies within the Pharmaceutical, Medical and Food industries. We have solutions for many applications such as sterilization, freeze drying, environmental chambers, heat tunnels, pasteurization and many more.

We develop unique and innovative solutions based on input from our close interaction and dialogue with our customers. Our goal is to help our customers overcome challenges and increase their productivity by providing reliable and efficient solutions that are supported by a responsive and competent service team.

Ellab has a long tradition and dedication for delivering the highest performance and quality in our industry. Our user-friendly, flexible thermal validation and monitoring solutions are recognized and used by thousands of customers worldwide.

Ellab is ISO 9001 & ATEX IEC 80079-34 certified. Our calibration laboratories in Denmark are accredited according to ISO 17025 by DANAK under registration no. 520 and our German laboratory also has an ISO 17025 accreditation, which is accredited by DAkkS. We also have a UKAS accreditation at our monitoring manufacturing site in UK.

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