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Maintenance Reliability Lead, RTP Bio
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Biogen Idec Research Triangle Park, United StatesCompany DescriptionJob Description · About This Role: · This key leadership role within the Engineering & Facilities organization will establish and oversee the Maintenance Reliability Function, reporting to the Head of Engineering & Facilities and serving as an active participan ...
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Reliability Program Manager
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Biogen Idec Research Triangle Park, United StatesCompany DescriptionJob Description · This individual contributor who will report to the Head of Facilities Engineering Technical Authority is accountable for the development and implementation of a comprehensive reliability program that ensures the reliability, availability, and ...
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Sr Tech II, Instrumentation
3 weeks ago
Biogen Idec Research Triangle Park, United StatesCompany DescriptionJob Description · The Sr. Tech II, I&C performs corrective and preventative calibrations on manufacturing and laboratory analytical instrumentation with limited supervision. Supports manufacturing and laboratory personnel in the use, maintenance and repair of o ...
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Sr Tech I, Instrumentation
3 weeks ago
Biogen Idec Research Triangle Park, United StatesCompany DescriptionJob Description · About This Role · Performs corrective and preventative calibrations on manufacturing and laboratory analytical instrumentation. Supports manufacturing and laboratory personnel in the use, maintenance and repair of on-site instrumentation and t ...
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Academy - Professional Services Associate
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Engineer - Facilities and Building Operations
4 weeks ago
Biogen Research Triangle Park, NC, United StatesEngineer II, Instrumentation and Controls provides engineering technical support and troubleshooting for Manufacturing Process / Utilitiy Equipment and Laboratory Analytical instrumentation. This position partners with other teams including Utilities, Manufacturing, Process Engin ...
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Site Services Coordinator
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DivIHN Integration, Inc Research Triangle Park, United States Contract*Title: Site Services Coordinator* · *Location: Research Triangle Park, NC* · *Duration: 10 Months* · *Expected Schedule: Monday - Friday 8:00 AM - 5:00 PM. Possibility of voluntary overtime.* · *Responsibilities* · Maintain core vendor management with facilities related to vendo ...
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Sr Engineer II, Instrumentation
4 weeks ago
Biogen Research Triangle Park, NC, United StatesJob Description · About This Role · The Sr. Engineer II, Instrumentation and Controls provides engineering technical support and troubleshooting for Manufacturing Process / Utilitiy Equipment and Laboratory Analytical instrumentation. Participates in multi-functional teams to i ...
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Software Engineer in Test
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Randstad USA Research Triangle Park, United States Freelance, Full timejob summary: · Location: - NC - only considering local candidates to start · Skills: - JavaScript/Typescript - Appium - - Playwright - Jenkins · The Team · We are a Quality Engineering focused organization with experience in all aspects of application delivery in an agile enviro ...
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Manufacturing Process Maintenance Technician III
4 weeks ago
Biogen Research Triangle Park, NC, United StatesJob Description Shift Information · This position will work a 10-hour shift Monday- Thursday or Tuesday- Friday. Weekends will be required on a rotating basis. · A Manufacturing Technician III will provide customer-oriented service and support in a fast-paced manufacturing envi ...
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Manufacturing Process Maintenance Technician III
4 weeks ago
Biogen Research Triangle Park, NC, United StatesJob Description · Shift Information · This position will work a 10-hour shift Monday- Thursday or Tuesday- Friday. Weekends will be required on a rotating basis. · About the Job · A Manufacturing Technician III will provide customer-oriented service and support in a fast-pace ...
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Manufacturing Process Maintenance Technician III
3 weeks ago
Biogen Idec Research Triangle Park, United StatesCompany DescriptionJob Description · Shift Information · This position will work a 10-hour shift Monday- Thursday or Tuesday- Friday. Weekends will be required on a rotating basis. · About the Job · A Manufacturing Technician III will provide customer-oriented service and support ...
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Manufacturing Specialist III, Mfg Tech Ops
1 month ago
Biogen Idec Research Triangle Park, United StatesCompany DescriptionJob Description · About this Role · In this Small Scale Manufacturing (SSM) Manufacturing Specialist II role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requ ...
Quality Engineering Associate - Research Triangle Park, NC, United States - Biogen
Description
The Quality Engineering (QE) Associate III is responsible for the oversight of key functional, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility.
The QE Associate III will perform all duties in a manner consistent with site and corporate policies, cGMPs, safety, environmental and human resources policies and procedures and be proficient in their understanding of the Biogen Quality Systems and apply that knowledge in coaching and continuous improvement for all Quality System cross-functionally.
Review and approve facility, utility, equipment, analytical instruments and automation lifecycle documentation including; User Requirements, Specifications, Drawings, Risk Assessments, Test Protocols, Deviations, Reports, Procedures and Periodic Reviews.
Review and approve changes affecting validated analytical instruments, manufacturing processes, equipment, facility, utility, automation systems, material/components, and business processes associated with IT GMP computerized systems.
Provide cGMP guidance and quality risk management support of manufacturing on the floor issues with equipment or systems, including review and approval of deviations and Corrective/Preventive Actions (CAPAs)Support the site changeover program by providing oversight of multi-product equipment inspection and release including the review of changeover documentation, sampling, elastomer replacement, carry-over calculations, engineering configuration, summary reports and equipment release.
Support site capital projects by providing GMP guidance, risk management input and quality oversight during shut down planning, release and other major equipment/facility improvements.
Develop and implement aspects of various Quality Systems/System Improvements.You are a motivated QA expert with sound Drug Manufacturing/Engineering experience/knowledge who is capable of being flexible with changing priorities.
Bachelor's Degree, preferably in Engineering, Life Sciences or related Technical discipline.~Thorough knowledge of FDA/EMA regulations including Current Good Manufacturing Practices (cGMPs) and International Council for Harmonization (ICH) guidelines.
~ Demonstrated troubleshooting and strong problem-solving skills and the ability to develop innovative/creative solutions to issues of moderate complexity.
Experience in Engineering and/or Validation (Equipment, Cleaning, Computerized Systems).
Experience with Quality Systems oversight and development.
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.
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.
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.
