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Validation Engineer

Job Location
Fargo, ND 58104
United States
Job Description

We are seeking a qualified Validation Engineer to join the Aldevron team.  As a Validation Engineer, you will write and review validation (verification, IOQ, PQ, and PV) documents, conduct or coordinate performance testing and perform or oversee the validation of facilities, equipment, utilities, laboratories, equipment, and processes. Involved in validation monitoring activities, which include audits with the system owner and review of operational documents. Participates in process development and process validation activities, including cleaning, shipping and continued process verification.

About The Role:

  • Write standard operating procedures describing process validation principles and activities as well as Validation Plans for functional areas and/or projects focusing on process and cleaning validation.
  • Actively participate during all phases of process validation: evaluate projects, provide guidance and technical information to co-workers. Write and review validation documents to support FAT, commissioning, IOQ, PQ, PV activities including protocols and final reports.
  • Write and review validation documents related to facilities, equipment, utilities, laboratories and equipment, or process validation systems comprising check for compliance with corporate standards, regulatory requirements and technical expertise.
  • Review engineering drawings (P&IDs, against, as-built), TOP documentation.
  • Review validation packages for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data analysis. Compare results against acceptance criteria and bring exceptions and deviations to management's attention. Recommend to management as to the acceptance and release of qualified systems.
  • Execute and/or coordinate/supervise execution of process, cleaning, shipping and continued process verification activities.
  • Executes process validation for new processes as well as legacy processes and requalifications.

About You:

  • 5-6 years of experience in Validation or Quality Departments or an equivalent combination of education and experience.
  • Validation experience including one or more of the following areas: process validation, cleaning validation, shipping validation, process development, media fill simulations, air flow visualization, validation, process equipment validation and continued process verification.
  • Experience drafting Validation Master Plans and Validation Project Plans.
  • Knowledge and practical experience using statistics in validation including statistical process control and use of statistics to set acceptance criteria and evaluate process data.
  • Knowledge of the regulatory and cGMP regulations for pharmaceutical manufacturing operations, and validation procedures and practices.


  • B.A. or B.S. in Biology, Biochemistry, Engineering or related science 

Who is Aldevron?

Aldevron is a leader in advancing biological science. Our custom development and manufacturing services provide scientists around the world with the essential components to accelerate research and open up their laboratories for groundbreaking science and breakthrough discoveries.

Why choose Aldevron?

We are in a landmark moment in the history of life science, and Aldevron is at the center of it. With our commitment to quality, we provide career opportunities that allow employees to grow and succeed, while helping make everybody's lives better.

Eligibility to work in the U.S. is required.

How to Apply

For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. 

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