- A key attribute of this position includes assessment of existing strategies to identify areas for continuous improvement and development of new strategies for sterility assurance programs, including Contamination Control Strategy, Aseptic Process Simulation, Filter Validation, Container Closure Validation, Leaks and Glove Management, Environmental Monitoring, Facility Disinfection, Gowning and Hygiene, and Sterility Assurance Risk Management programs.
- The scope of the role includes syringe filling and device assembly & packaging operations for commercially manufactured products targeted for transfer to the RTP site.
- Lead and / or assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.)
- Assists with writing of regulatory submissions for sterility assurance programs.
- Create, review, approve and provide sterility assurance training for new hires and personnel from other sites.
- Provide technical mentorship to a less senior scientists within the TS/MS organization.
- Provide technical mentorship to a less senior cross-functional personnel within RTP.
- BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
- 10 years' experience in the biopharmaceutical industry
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Technical Services Engineer
1 week ago
Jones Lang LaSalle Incorporated Durham, United StatesTechnical Services Engineer page is loaded · Technical Services Engineer · Apply · remote type · On-site · locations · Durham, NC · time type · Full time · posted on · Posted 3 Days Ago · job requisition id · REQ349737 · JLL supports the Whole You, personally and pro ...
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Sterility Technical Services
2 weeks ago
Wealth Recruitment, LLC Durham, United StatesA key attribute of this position includes assessment of existing strategies to identify areas for continuous improvement and development of new strategies for sterility assurance programs, including Contamination Control Strategy, Aseptic Process Simulation, Filter Validation, Co ...
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Client Services And Technical Support
6 days ago
DCS Lab Durham, United StatesJob Description · Job DescriptionJob Title: Technical & Client Support · Location; Durham, North Carolina · Benefits: Full · Salary: 50-75k depending on experience · Awesome opportunity for Dental Technician or Dental Assistant that need a change · Job Description: · Customers/De ...
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Sr. Associate II, Quality Technical Services
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Biogen Durham, United States Full timeJob Description · The Quality Technical Services & Compliance (QTSC) Senior Associate II is responsible for understanding quality systems, contributing to oversight of quality systems, and for the oversight of key functional and operational aspects within Quality Assurance at the ...
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Sr. Associate II, Quality Technical Services
4 weeks ago
Biogen Durham, United States OTHERJob Description · The Quality Technical Services & Compliance (QTSC) Senior Associate II is responsible for understanding quality systems, contributing to oversight of quality systems, and for the oversight of key functional and operational aspects within Quality Assurance at the ...
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Lilly Durham, United States Full timeWe're looking for people who are determined to make life better for people around the world. · Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exci ...
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Laborer - Mears Electric
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QC Associate
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Actalent Durham, United States Full timeDescription: · Our client, a global CDMO in pharmaceutical manufacturing providing process development and cGMP production in cell culture, microbial fermentation and gene therapies, is looking for a Quality Control Associate to support their Environmental Monitoring, Bioburden a ...
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Adjunct Training Manager
5 days ago
University of New Hampshire Durham, United StatesPosition Information · **Operating Title** · - Adjunct Training Manager**Summary of Position** · - This is a part time position, comprising of 20 hours per week, supports the National Center for Start Services (NCSS) program under the Director of Training and Professional Develop ...
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Cable Splicer
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Eli Lilly and Company Durham, United States Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve th ...
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Aerospace Project Engineer
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Senior Consultant Software Test
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Stellar Enterprises Durham, United StatesAbout Trimetis GFB IT-Consulting GmbH: · Founded in 1997, the company has evolved from a software training company spin-off to a specialized IT service provider with a focus on software testing consulting. The main areas of expertise include Test Data Management (TDM), Test Autom ...
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FusionWorks Durham, United StatesThe German Railway is not only one of the most important mobility service providers, but also one of the largest engineering firms in Germany. Currently, more than engineers work for us to realize and sustainably maintain new bridges, tunnels, train stations, tracks, and signal s ...
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Eli Lilly and Company Durham, United States Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve th ...
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Manager, Technical Services
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Arista Networks Cary, United StatesArista Networks was founded to pioneer and deliver software driven cloudnetworkingsolutions for largedatacenter storage and computing environments. Arista's award-winning platforms, ranging in Ethernet speeds from 10 to 400 gigabits per second, redefine scalability, agility and r ...
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Manager, Technical Services
1 day ago
Arista Networks Inc Cary, United StatesAttract and hire exceptional talent, aligned to Arista's culture and business. Define the responsibilities and expectations of each engineer on the team. Solicit, document, and provide balanced feedback on their performance, addressing opportunities Technical, Manager, Customer E ...
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Manager, Technical Services
1 week ago
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Technical Service Manager
1 week ago
Monro Muffler Brake Burlington, United States**Technical Service Manager** · Burlington, NJ 08016, USA · Full-time · Department: District 35 · **Company Description** · **Monro, Inc.** · Monro, Inc. is one of the nations largest auto service companies and major tire retailer. We own and operate more than 1,200 stores ...
Sterility Technical Services - Durham, United States - Wealth Recruitment, LLC
Description
Job Description
Job DescriptionThe Sterility Assurance Steward implements 3 primary objectives:
(1) reliable, compliant manufacturing of the drug product.
(2) improvement of the process control strategy, continuous optimization, development of technologies.
(3) continual deepening of the scientific understanding of sterility assurance. The technical agenda exists throughout the entire product, process, and facility lifecycle.
Requirements
Sterility Technical Services professionals in Durham
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James DeCarlo
Permanent or contract Validation Engineer.