- Responsible for supporting manufacturing operations by troubleshooting process equipment system issues and identifying improvements. Update preventative maintenance job plans, equipment standards, drawings and specifications as necessary.
- Identify and lead process equipment related projects, including technology transfers, capital projects, and modifications. Provide input & guidance to Tech Transfer and area efforts, provide technical evaluations of process equipment including validation requirements for change controls and associated action plans.
- Author and approve Trackwise generated workflows (change controls, deviations, CAPAs) for equipment/automation related changes, impact assessments, review automation protocols, and attend related meetings.
- Coordinate process equipment/cleaning validation protocols (development, management, tracking) including time spent on manufacturing floor. Specifically design and develop validation protocols, provide expertise to associated equipment and automation design / modifications, support FAT (Factory Acceptance Testing), equipment startup, & commissioning efforts, as required.
- Provide support with presenting discussion topics during health authority (e.g. - FDA) and partner inspections with regards to engineering and validation practices and policies.
- Bachelor's degree in engineering or other highly technical discipline.
- Minimum of 4 years of experience in process equipment engineering, preferably in a biologics drug substance environment.
- Experience with bioreactor, centrifugation, chromatography and/or viral/ultra-filtration unit operations preferred.
- Practical knowledge and application of GMP regulations and guidelines (ISPE, USP, PIC/S, Annex, ICH, etc.).
- Competency in DeltaV, MS Word, MS Excel, MS Power Point and MS Project.
- Excellent organization, time management, oral and written communication skills.
- Ability to work on-site.
- Ability to work rotating shifts/on-call, extended coverage support and weekends as needed.
-
Maintenance Reliability Lead, RTP Bio
2 days ago
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 ...
-
Sr Tech I, Instrumentation
2 days 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 ...
-
Sr Tech II, Instrumentation
2 days 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 ...
-
Reliability Program Manager
2 days ago
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 ...
-
Sr. Associate Scientist
3 weeks ago
Biogen Idec Research Triangle Park, United States Full time· Job Description · About This Role · The Sr. Assoc. Sci/Engineer III will contribute as a scientific resource for purification in Mfg Sciences on drug substances manufactured at Biogen's RTP facility. They will provide technical expertise on chromatography and filtration step ...
-
Senior Reliability Engineer I
1 week ago
Biogen Idec Research Triangle Park, United StatesCompany DescriptionJob Description · The Sr. Reliability Engineer I applies Reliability Engineering methodologies to optimize design requirements and performance of critical assets across the site. Originates and develops analysis methods for determining reliability of components ...
-
Travel Medical Lab Technician
2 weeks ago
TalentBurst, Inc Research Triangle Park, NC, United StatesTalentBurst, Inc is seeking a travel Medical Lab Technician for a travel job in Research Triangle Park, North Carolina. · Job Description & Requirements · Specialty: Medical Lab Technician · Discipline: Allied Health Professional · Start Date: ASAP · Duration: 32 weeks · 40 hours ...
-
Quality Engineering Associate
6 days ago
Biogen Research Triangle Park, NC, United StatesThe 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 ...
-
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 ...
-
Associate III, Quality Engineering
6 days ago
Biogen Research Triangle Park, NC, United StatesJob Description · About the Role · 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 al ...
-
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 ...
-
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 ...
-
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 ...
-
MLT - Laboratory - Travel
2 weeks ago
TalentBurst, Inc Research Triangle Park, NC, United States TemporaryTalentBurst, Inc is seeking a travel Medical Lab Technician for a travel job in Research Triangle Park, North Carolina. · Medical Lab Technician · ~ Discipline: Allied Health Professional · ~ Start Date: ASAP · ~ Shift: 8 hours · ~ Employment Type: Travel · Laboratory Techn ...
-
Sr Engineer II, Instrumentation
5 days 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 ...
-
Sr Engineer II, Instrumentation
6 days 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 ...
-
Reliability Engineering M
6 days ago
Biogen Research Triangle Park, NC, United StatesReliability Engineer I applies Reliability Engineering methodologies to optimize design requirements and performance of critical assets across the site. Originates and develops analysis methods for determining reliability of components, equipment and processes. Acquires data and ...
-
Sr. Reliability Engineer I
6 days ago
Biogen Research Triangle Park, NC, United StatesJob Description · The Sr. Reliability Engineer I applies Reliability Engineering methodologies to optimize design requirements and performance of critical assets across the site. Originates and develops analysis methods for determining reliability of components, equipment and pr ...
-
Manufacturing Specialist III, MFG Tech Ops
2 weeks ago
Biogen Idec Research Triangle Park, United States Full time· Job 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 requires you to be ...
-
Manufacturing Specialist III, Mfg Tech Ops
2 weeks 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 ...
Sr. Engineer I, Manufacturing - Research Triangle Park, United States - Biogen Idec
Description
Job Description
The Manufacturing Sr Engineer I designs, specifies, installs, commissions and validates new process equipment, provides engineering technical support and troubleshooting for assigned process equipment and a GMP biological manufacturing area such as Cell Culture, Harvest or Purification. The incumbent would support technology transfer of new processes into the facility, provide project engineering support as required for new process equipment installations and modifications to existing process equipment and have the ability to manage medium to large engineering projects with little direction. In addition, they would develop validation protocols, oversee validation testing and final report approvals. This role will work with and provide some direction to contractors and participate in and lead multi-function teams to implement change and improvements on existing processes.
What You'll Do
You are an experienced process equipment engineer who likes to troubleshoot and investigate improvements to increase site operations and passionate about learning new technologies and working in a cross-functional environment. 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
Qualifications
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.
