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Process Validation Engineer (Pharma)

Company: Danaher Corporation
Location: Boise
Posted on: May 28, 2023

Job Description:

At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.
Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
Role Summary:
This position is part of the Validation Engineering team located in Fargo, ND and will be on-site in North Dakota. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide.
In this role, you will have the opportunity to:

  • Support internal and external Process Validation and Robustness activities with projects focused on biological drug product manufacturing.

  • Support applicable ancillary validations to ensure the production environment is compliant with regulatory requirements.

  • Be an active member on cross-functional teams, supporting Aldevron initiatives.

  • Review validation packages for completeness and accuracy, scientific rationale, compliance with validation policies and procedures, and accurate data analysis. Compare results against acceptance criteria and lead the resolution of deviations. Act independently to execute approved resolutions. Recommend to QA the release of qualified systems.

  • Write and review validation documents related to facilities, drug product, cleaning or process validation systems comprising check for compliance with corporate standards, regulatory requirements, and technical expertise. Lead cross functional review and implementation / execution of documentation with clients or internal stakeholders.

  • Compile, maintain, analyze and make recommendations for value-generating solutions based on data from multiple sources supporting R&D, engineering and validation work. Execute solutions independently.

    The essential requirements of the role include:

    • B.A. or B.S. in Biology, Biochemistry, Engineering, or related science with a minimum of 5 years of experience in GMP drug product manufacturing -OR- a Master's with 3 years of experience.

    • At least 1+ years of experience with Cleaning Validation, Process Validation and/or Media Fill Simulation.

      Key attributes and skills desired:

      • Experience with LNP manufacturing is a plus

        When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System ( tools and the stability of a tested organization.
        Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here ( .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation. If you've ever wondered what's within you, there's no better time to find out.

Keywords: Danaher Corporation, Boise , Process Validation Engineer (Pharma), Engineering , Boise, Idaho

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