Engineer III Manufacturing
Engineer III Manufacturing
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Salary Not Disclosed
1 Vacancy
Job Description
About This Role
The Engineer III Manufacturing designs specifies and installs new equipment and provides engineering technical support and troubleshooting for assigned process equipment and area assets. Develops validation protocols oversees validation testing and drafts final reports. Provides project engineering as required for new processing equipment installations and modifications to existing equipment.
What Youll Do
- Support Manufacturing operations by troubleshooting issues and identifying equipment system improvements. Update standards drawings and specifications as necessary.
- Identify and lead equipment related projects including technology transfers capital projects and modifications. Complete project management tracking of deliverables for metrics & reporting. Provide input & guidance to Tech Transfer and project / area efforts provide technical evaluations of validation requirements for core change controls & associated action plans.
- Author sections of Validationrelated reports & project plans approve Trackwisegenerated workflows (deviations global change controls) for equipment / automationrelated changes review automation protocols & attend related meetings.
- Coordinate Equipment/Cleaning Validation Protocols (development training management tracking) includes time spent on production floor. Specifically design & develop validation protocols provide expertise to associated equipment & automation design / modifications support FAT (Factory Acceptance Testing) equipment startup & commissioning efforts as required.
Who You Are
You are accountable for achieving milestones in equipment projects involving frequent internal and external communication. As a representative of the Manufacturing Engineering organization your role carries the weight of potential delays and extra resource allocation if errors occur in your decisions or recommendations. Your commitment lies in delivering accurate and timely results ensuring efficient processes to prevent setbacks.
Qualifications :
- Bachelors degree in engineering.
- Practical knowledge and application of GMP and EMA regulations.
- 24 years of experience in manufacturing preferably in a pharmaceutical or biotech environment.
- Competency in Process Controls and Distributed Controls Systems MS Word MS Excel MS Power Point and MS Project.
- Excellent oral and written communication skills.
- Ability to work rotating shifts extended shifts (including weekends) and on call as needed.
- Experience with either Fill Finish Isolator (Bausch and Stroebel) and Lyophilizer technologies preferred.
Additional Information :
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished 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. Above all we work together to deliver lifechanging medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an EVerify Employer in the United States.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
