Senior Facilities Validation Engineer

7 days ago


Golden Triangle, New Jersey, United States Biogen Full time
Job Summary

We are seeking a skilled Senior Facilities Validation Engineer to join our team at Biogen.

The estimated annual salary for this role is $120,000 - $180,000, depending on experience and location.

About the Role

This position plays a crucial part in ensuring the smooth operation of our facilities. You will be responsible for providing technical support and validation for plant utilities and facilities, participating in multi-functional teams to implement changes and improve existing processes.

  • Main Responsibilities:
  • Troubleshoot issues and identify equipment system improvements to support facilities operations.
  • Develop and execute validation protocols, provide expertise to associated equipment & automation design modifications, and author deviations, CAPA's and/or change control records in a GMP environment.
  • Support equipment-related capital and op-ex projects, including scoping, modifications, design reviews, change controls, construction support, commissioning, and validation.
  • Represent the department and lead/participate in cross-functional/global teams to address issues, implement change, and improve existing processes.
Requirements

To succeed in this role, you should have:

  • A Bachelor's degree in Engineering and 2+ years of transferrable experience.
  • Practical knowledge 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

We also welcome candidates with experience in biotechnology/pharmaceutical manufacturing environments, writing deviations, conducting investigations, and project management.

About Biogen

Biogen is a global biotechnology company committed to excellence and innovation. We foster an inclusive work environment where individual contributions make a significant impact. Our team is dedicated to delivering life-changing medicines that improve patients' lives.



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