Senior Facilities Validation Engineer
7 days ago
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 RoleThis 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.
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.
We also welcome candidates with experience in biotechnology/pharmaceutical manufacturing environments, writing deviations, conducting investigations, and project management.
About BiogenBiogen 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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