Job Description
About This Role
The Engineer III provides engineering technical support and validation for plant utilities and facilities. Participates in multi-functional teams to implement changes and improve on existing processes. This position partners with other teams including Utilities, Manufacturing, Process Engineering, Maintenance, and others to validate all GMP assets. Supports design, specification, installation, commissioning, and qualification of new equipment including URS and protocol writing and executions. Participates and leads engineering projects with minimal supervision and direction.
What You'll Do
- Supports Facilities operations by troubleshooting issues and identifying equipment system improvements. Updates standards, drawings, and specifications as necessary. Develops validation protocols, provides expertise to associated equipment & automation design modifications. Author deviations, CAPA's and/or change control records in a GMP environment.
- Supports equipment related capital and op-ex projects, including scoping, modifications, design reviews, change controls, construction support, commissioning, and validation.
- Develops and executes equipment commissioning and qualification (validation) activities.
- Represent department and lead/participate in cross-functional/global teams to address issues, implement change and improve existing processes.
- Complete work tasks with oversight from Facilities Engineering Manager
- Manage small capital projects.
- Maintain personal training, goal development/completion, investigations, compliance workflow activities, and progress tracking.
Who you are
You are an experienced validation engineer who likes to lead development of IQ/OQ/PQ documentation. You are passionate about working in a cross-functional environment where you are facilitating validation project execution. You thrive in lending your expertise to others in the team. You are solution driven and enjoy continuous improvement. You easily recognize cost savings and pride yourself in driving safety enhancements. As a representative of the Facilities Engineering team you role carries the weigh of potential delays and extra resource allocation if errors occur in your decisions or recommendations.
Qualifications
- 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.
- May be asked to work extended shifts or weekends.
Preferred Qualifications
- Experience with Kaye and LIVES validation dataloggers.
- Experience in biotechnology/pharmaceutical manufacturing environment.
- Experience writing deviations and conducting investigations
- Project management experience
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, 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. Above all, we work together to deliver life-changing 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 E-Verify Employer in the United States.
