We are desiring to recruit a driven Sr. Engineer I, Manufacturing to join our knowledgeable team at Biogen Inc in Research Triangle Park, NC.
Growing your career as a Full Time Sr. Engineer I, Manufacturing is a great opportunity to develop necessary skills.
If you are strong in adaptability, attention to detail and have the right mindset for the job, then apply for the position of Sr. Engineer I, Manufacturing at Biogen Inc today!
Job Description This role 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. Aids in the development of junior process engineers as appropriate. Able to manage small to medium engineering projects with little direction. Work with and provide direction to contractors. Lead multi-function teams to implement change and improve on existing processes.
This Responsible Engineer has some experience in manufacturing processes related to their assigned subject matter expertise. They would be starting to develop their technical expertise and would be expected to work collaboratively with cross-functional teams to deliver results under the guidance of more senior team members.
What You'll Do Support Manufacturing operations by troubleshooting issues and identifying equipment system improvements. Updates 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 Validation-related reports & project plans, approve Trackwise-generated workflows (deviations, global change controls) for equipment / automation-related changes, reviews automation protocols, & attends related meetings. Coordinate Equipment/Cleaning Validation Protocols (development, training, management, tracking) - include 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. Maintain personal training, goal development / completion, compliance workflow tracking, & progress tracking. Who You Are You are accountable for achieving milestones in equipment projects, involving frequent internal and external communication. As a representative of the Process 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 Required Skills Bachelor Degree in Engineering or other highly technical discipline or acceptable combination of education and practical experience. Practical knowledge and application of GMP and EMA regulations. Minimum 4-6+ plus experience in pharmaceutical or biotech manufacturing 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 and weekends as needed. Assignments are complex in nature where ability to recognize deviation from accepted practice is required. Judgment is required in resolving problems & making routine recommendations. Broad understanding of the detailed aspects of the job. Applies job skills and company policies and procedures to complete a variety of tasks. Fill Finish experience required, with Isolator (Bausch and Stroebel) and Lyophilizer technologies. Additional Information Leads implementation of new manufacturing processes and technology transfers for new products or modifications to existing products. Investigates process or equipment failures and implements changes to avoid future occurrences. Support creation of new procedures for equipment and systems in Engineering and Manufacturing. Why Biogen? Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
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.
Benefits of working as a Sr. Engineer I, Manufacturing in Research Triangle Park, NC:
? Company offers great benefits
? Room for Advancement
? Leading Industry Pay
