- 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.
- Bachelor's degree in engineering or other highly technical discipline
- Minimum of 2 years of experience in manufacturing, engineering or validation, 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.
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Engineer III, Manufacturing
2 weeks ago
Biogen Durham, United StatesThe 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 Manufacturing, Technical Supp ...
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Manufacturing Technician III
1 week ago
Biogen Durham, United StatesShift Information This position will work a 2,2,3 schedule working 12-hour shifts. Flexibility for night shift coverage may be required. About the Job A Manufacturing Technician III will provide customer-oriented service and support in a fast-paced m Manufacturing Technician, Tec ...
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Manufacturing Technical Operations III
1 week ago
HUMACYTE GLOBAL INC Durham, United StatesJob Description · Job DescriptionManufacturing Technical Operations III · Position Profile · Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on i ...
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Manufacturing Process Maintenance Technician III
4 hours ago
Biogen Durham, United States Full timeJob 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 Durham, United States Full timeJob Description · Shift Information · This position will work a 2,2,3 schedule working 12-hour shifts. Flexibility for night shift coverage may be required. · About the Job · A Manufacturing Process Maintenance Technician III will provide customer-oriented service and support ...
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Manufacturing Process Maintenance Technician III
2 weeks ago
Professional Diversity Network Durham, United States Full timeBiogen · Job 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 fas ...
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Manufacturing Process Maintenance Technician III
3 weeks ago
Biogen Durham, United States OTHERJob Description · Shift Information · This position will work a 2,2,3 schedule working 12-hour shifts. Flexibility for night shift coverage may be required. · About the Job · A Manufacturing Process Maintenance Technician IIIwill provide customer-oriented service and support in a ...
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Manufacturing Specialist III, MFG Tech Ops
4 weeks ago
Biogen Durham, United States OTHERJob 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 high ...
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Engineer III, Manufacturing
3 weeks ago
Biogen Raleigh, United StatesJob Description · Job Description Job Description · About This Role · The Manufacturing Engineer III designs, specifies, installs, commissions and validates new process equipment, provides engineering technical support and troubleshooting for assigned process equipment and a GM ...
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Engineer III, Manufacturing
2 weeks ago
Biogen Raleigh, United StatesThe 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. Provide ...
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Manufacturing Engineer III
1 week ago
Auria Solutions , Ltd. Raleigh, United StatesProject Engineering Coordinator ( · PEC · ) · Job Description · Responsibilities · Active participant in procurement process. · ( · Focused on tooling) · Specification · reviews · , · Supplier · R · equest · for · Q · uotes · Quotation reviews · (cost, · timing, · ...
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Manufacturing Process Maintenance Technician III
2 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 Engineer III
3 weeks ago
Auria Solutions , Ltd. Raleigh, United StatesManufacturing Engineer · Develop and identify equipment necessary for new programs and products · Develop capital estimates for ECR's and new launches · Specify capital equipment for processes required for ECR changes and new launches · Manage capital projects, ensuring complian ...
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Manufacturing Process Maintenance Technician III
2 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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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 team leader iii
3 weeks ago
TE Connectivity Raleigh, United States**At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.** · ****Job Overview**** · * Provides work direction and coordinates the activities of R&D and operating workers on the li ...
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Manufacturing Specialist III, MFG Tech Ops
3 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 ...
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Manufacturing Specialist III, Mfg Tech Ops
3 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 ...
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Sr. Engineer III, Automation
2 weeks ago
Biogen Durham, United StatesReporting to the Head of RTP Site Automation, the Sr. Engineer III is a Subject Matter Expert (SME) in Distributed Control Systems (Delta. V DCS), Building management Systems (Rockwell BMS), Automation for Manufacturing Execution Systems (Syncade MES Automation, Engineer, Reliabi ...
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Engineer III, Automation
2 weeks ago
Biogen Durham, United States#xa 0;About This Role. The Automation Engineer III provides 24/7 process controls/automation technical site support to the Biogen 900 Davis drive, NC manufacturing site. In addition, this role manages multiple small OPEX/ CAPEX projects and continuou Automation, Continuous Improv ...
Engineer III, Manufacturing - Durham, United States - Biogen
Description
Job Description
Do you have the skills to fill this role Read the complete details below, and make your application today.About This Role
The Manufacturing Engineer III 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 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
Who You Are
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 commitment lies in delivering accurate and timely results, ensuring efficient processes to prevent setbacks.
Qualifications
Additional Information
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.
PDN-9bd16ea7-d a6d9-9533c835477d
Engineer III, Manufacturing professionals in Durham
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James DeCarlo
Permanent or contract Validation Engineer.