Senior Validation Engineer

4 weeks ago


Denver, Colorado, United States Biogen Full time
Job Summary

Biogen is seeking a highly skilled Senior Validation Engineer to join our Facilities Engineering team. As a key member of our team, you will be responsible for providing engineering technical support and validation for plant utilities and facilities. This role requires a strong understanding of FDA GMP and EMA regulations, as well as experience with validation protocols and equipment commissioning.

Key Responsibilities

- Provide engineering technical support and validation for plant utilities and facilities
- Participate in multi-functional teams to implement changes and improve existing processes
- Develop and execute equipment commissioning and qualification (validation) activities
- Represent the department and lead/participate in cross-functional/global teams to address issues, implement change and improve existing processes

Requirements

- BS in Engineering and 2+ years of transferrable experience
- Practical knowledge of the application of FDA GMP and EMA regulations
- Competency in MS Word, MS Excel, MS Power Point, MS SharePoint and MS Project
- Plant Utility and chamber Validation experience
- Excellent oral and written communication skills

Preferred Qualifications

- Experience with Kaye and LIVES validation dataloggers
- Experience in biotechnology/pharmaceutical manufacturing environment
- Experience writing deviations and conducting investigations
- Project management experience

About Biogen

Biogen is a global team with a commitment to excellence, and a pioneering spirit. We provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. We work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

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