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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 Technical Operations II
2 weeks ago
HUMACYTE GLOBAL INC Durham, United StatesJob Description · Job DescriptionManufacturing Technical Operations II · 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 im ...
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Manufacturing Technical Lead, Line 4
3 weeks ago
bioMérieux Durham, United StatesBenefits at bioMerieux: · Low-cost medical, dental, and vision benefits starting day one · 11 paid holidays · 160 hours of paid time off · Annual bonus · 9.5% 401k company contribution with no vesting period · Tuition reimbursement up to $10,000 per calendar year · Onsite ...
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Biogen Durham, United StatesAbout This Role:This critical position provides operational oversight of the Manufacturing Technical Operations (MTO) function for the Small Scale Manufacturing (SSM) and Flexible Volume Manufacturing (FVM) factories at out RTP Bio Site. This positio Technical, Operations, Manufa ...
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Biogen Durham, United StatesJob Description · Remember to check your CV before applying Also, ensure you read through all the requirements related to this role. · About This Role: · This critical position provides operational oversight of the Manufacturing Technical Operations (MTO) function for the Smal ...
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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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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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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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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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QC Associate
2 weeks ago
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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Associate Scientist
1 week ago
Actalent Durham, United States Full timeDescription: · The Associate Scientist position will work within the manufacturing team to execute viral vector production using (hands-on) both upstream and downstream operation activities for use in gene therapy applications. The Associate Scientist will also support in routine ...
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Manufacturing Technical Applications Specialist
2 weeks ago
ABB Cary, United StatesManufacturing Technical Applications Specialist · Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion ...
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Manufacturing Technical Applications Specialist
2 weeks ago
ABB Cary, United StatesManufacturing Technical Applications Specialist · Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusio ...
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Manufacturing Technical Applications Specialist
2 weeks ago
B&R Industrial Automation Cary, United StatesManufacturing Technical Applications Specialist · Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusio ...
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Aerospace Project Engineer
3 weeks ago
NovaWorks Durham, United StatesJob Description · What to expect in this role · Are you familiar with the topics of robotics and automation? · Our team in the Manufacturing Engineering department supports our client in the civil aviation industry with the implementation of projects in the areas of logistics, pr ...
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Manufacturing Technical Applications Specialist
3 weeks ago
ABB Cary, United StatesManufacturing Technical Applications Specialist · Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion ...
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FusionTech Durham, United StatesDo you have an understanding of technical concepts and possess manual skills? The apprenticeship as an industrial mechanic in the field of maintenance (m/f/d) offers you insights into the areas of electrical engineering, pneumatics, hydraulics, and computer science, and provides ...
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Manufacturing Engineering Technical Advisor
1 week ago
Cummins Raleigh, United StatesCummins Inc. · Manufacturing Engineering Technical Advisor · in · Maxton , · North Carolina · Manufacturing Engineering Technical Advisor · Description · Our culture believes in · POWERING YOUR POTENTIAL · . We provide global opportunities to develop your career, make your ...
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Technician - Maintenance - Night Shift
5 days ago
Lilly Durham, United StatesAt 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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HCG Technical Project Manager
2 weeks ago
Horizon Controls Group Durham, United StatesAs the Technical Project Manager, you will be responsible for overseeing the planning, execution, and closing of a complex automation project installation within a pharmaceutical environment. The project will involve installing new automated systems. · Responsibilities · Develop ...
Manager, Technical Manufacturing - Durham, United States - bioMérieux SA
Description
Position Summary:
The Manager, TechnicalManufacturing position is responsible for Front-line leadership of their teams.
All Technical / Autonomous Maintenance aspects of reagent formulation, production/packaging inspecting, preventive maintenance, cleaning, troubleshooting and/or repair of manufacturing/process equipment of their respective areas
May provide indirect leadership for other teams as assigned.
Provide technical line support
Execute Assigned Projects or Scope of Work
Monitor Equipment Performance
Collaborate with Engineering Validation Leadership
Lead and Participate in Engineering and Interdepartmental Team Meetings
Lead quality initiatives to improve manufacturing processes, increase product quality, improve departmental productivity/efficiency.
User Friendly Interfacing and Computing Innovations
Following regulatory and customer requirements.
Development of internal candidates by providing expanded responsibilities in relation to team leadership, including personnel performance management and accountability for team performance metrics and projects.
Primary Responsibilities:
Management
Coordinate department requests for equipment or personnel support that impact Manufacturing operations.
This may include but is not limited to Engineering, QC, R&D, Validation or Maintenance.
Oversee and assist Technicians in management of daily activities including scheduling cleaning activities.
Maintain an efficient and effective workforce.
Contribute to team goal development, status tracking and communication through the PMP (Performance Management Program) process Communicate with other departments (i.e.
Materials Management, Production Operations, and Quality Control as needed to ensure the timely and efficient production of all of our customer requirements.
Conduct meetings (team and/or safety) as needed, keep records/documentation of information discussed.Perform other duties as assigned by Management.
Leadership / Employee Development
Provide performance feedback coaching and development for Team Leads, Tech Leads, Setup Techs and/or team members.
Complete formal performance evaluations for all direct reports.
Inspire and motivate production teams to achieve top performance.
Promote self-growth and internal development within the team.
Demonstrate and work towards developing the following attributes:
Inspire, motivate, and guide others toward goal accomplishments. Consistently develop and sustain cooperative working relationships. Encourage and facilitate cooperation within the organization and with customer groups; foster commitment, team spirit, pride, and trust. Develop leadership in others through coaching, mentoring and guiding.
Convey goals and objectives clearly and in a compelling manner; listen effectively and clarify information as needed; interpret verbal and non-verbal messages that others communicate; produce clear status reports; communicates tactfully and candidly.
Execute Assigned Projects or Scope of Work
Manage project schedules and project budgets as assigned.
Work in a team environment to complete projects
Monitor Equipment Performance
Review SPC/OEE results, analyze data, and implement improvements as required.
Provide technical support for the area equipment and processes.
Review in-process scrap and act to improve as required.
Lead and Participate in Manufacturing and Interdepartmental Team Meetings
Actively participate and facilitate team meetings as required.
Act as SME to assigned projects or scope.
Assist project leaders to close the projects after they have been completed.
User Friendly Interfacing and Computing Innovations
Provide first line support for programming support.
Interdepartmental coordination including Operational Technology and Automation for the successful development and / or implementation of software programs.
Lead quality initiatives to improve manufacturing processes, increase product quality, improve departmental productivity/efficiency.
Documentation & Training Compliance
Utilize a variety of software systems to support daily work activities (i.e. Proficient/SPC, Rockwell, TrackWise, LiveLink/DocLink, SAP, BRAM, Compliance Wire, etc.).
Ensure overall team training compliance is maintained current for processes and procedures relevant to all activities and coordinate cross-training among roles to create staffing flexibility and increased depth.
Ensure that Manufacturing batch records and other documentation are prepared, completed and stored at the highest standards according to company policies and procedures to support manufacturing, maintenance of device history records, logs/logbooks and training requirements consistent with cGMP, ISO, and all applicable regulatory policies/regulations.
Provide assistance with the creation, review and revision of instructions and SOPs necessary for the Manufacture of BacT/ALERT products.Continuous Improvement
Lead and promote continuous improvement through team and individual initiatives.
Identify areas of deficiency and implement practices to improve employee safety and to reduce the cost incurred through excessive scrap, poor workflow/process design and others.
Lead project teams and/or serve as a project team member to reduce scrap, improve product quality, decrease operational costs, and increase departmental efficiency/productivity.
Serve as change agent by driving the required cultural transformation and the adoption of successful process improvement practices.Quality / Manufacturing Compliance
Coordinate with the shift Manufacturing Compliance team member(s) to mitigate errors via the Right The First Time (RTF) initiatives.
Ensure Quality Assurance is communicated to the team for minimal deviations and error free performance.
Maintaining the BacT/ALERT manufacturing operation so that it is GMP compliant and meets all regulatory requirements.
Review documentation to support manufacturing, maintenance history records and training requirements that adhere to all applicable procedures and regulations.
Ensure the most recent information related to manufacturing and maintenance is communicated and/or documented for compliance, history, and reliability.
Assist with and/or lead Manufacturing investigations, CAPA actions, In-Process Events (IPEs) and other process equipment related quality concerns.
Ensure that Manufacturing batch records and other documentation are prepared, completed and stored at the highest standards according to company policies and procedures to support manufacturing, maintenance of device history records, logs/logbooks and training requirements consistent with cGMP, ISO, and all other applicable policies and regulations.
Provide support in FDA, ISO, customer and other inspections and auditsEducation, Skills, & Experience:
HS Diploma with 6 years regulated production/ operations environment experience & 5 Years Supervisory Experience OR
Associates Degree or relevant Technical Certifications with 6 years regulated production/operations environment experience Experience + 4 Years Supervisory Experience OR
Bachelor's Degree with 5 years regulated production/ operations environment experience & 3 Years Supervisory Experience
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Manager, Technical Manufacturing professionals in Durham
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Dishant Gada
Business Analytics Graduate
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James DeCarlo
Permanent or contract Validation Engineer.