Current jobs related to Specialist Manufacturing: NPI, Process Owner - Holly Springs - Amgen

  • Manufacturing Digital Specialist

    1 month ago

    Holly Springs, United States Amgen Full time

    Join Amgens Mission of Serving PatientsAt Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology,...

  • Manufacturing Digital Specialist

    1 month ago

    Holly Springs, United States Amgen Full time

    Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on...

  • Manufacturing Process Specialist

    6 days ago

    Bonita Springs, Florida, United States Beacon Engineering Resources Full time

    Job Summary:As a Manufacturing Process Specialist at Beacon Engineering Resources, you will be responsible for developing and improving manufacturing processes to optimize workflow efficiency. This role involves designing and implementing new systems for production, collaborating with cross-functional teams to enhance product quality, and troubleshooting and...

  • Manufacturing Operations Specialist

    2 weeks ago

    Mount Holly Springs, Pennsylvania, United States Fujifilm Holdings Corp Full time

    Manufacturing Support Specialist 3 Job OverviewFUJIFILM Diosynth Biotechnologies is seeking a highly skilled Manufacturing Support Specialist 3 to join our team. As a key member of our manufacturing operations, you will be responsible for providing technical support and expertise to ensure the smooth operation of our production processes.Key...

  • Associate Director, Process Analytics Leader

    2 weeks ago

    Holly Springs, United States FUJIFILM Corporation Full time

    About This RoleWe are seeking a highly skilled Associate Director, Process Analytics to join our team at FUJIFILM Diosynth Biotechnologies Holly Springs (FDBN). As the system owner and responsible for setting the direction and execution of Manufacturing Intelligence/Process Analytics solutions, you will play a critical role in driving the success of our...

  • Manufacturing Engineer Specialist

    2 weeks ago

    Mount Holly, United States L3Harris Technologies Full time

    Job Title: Manufacturing Engineer SpecialistJob Overview:L3Harris Technologies is seeking a highly skilled Manufacturing Engineer Specialist to join our team. As a key member of our engineering team, you will be responsible for developing, implementing, and analyzing manufacturing engineering plans and projects.Key Responsibilities:Develop and implement...

  • Process Engineer

    1 week ago

    Chester Springs, Pennsylvania, United States Kelly Services, Inc. Full time

    Process Engineer - Pharmaceutical ManufacturingKelly Services, Inc. is seeking a highly skilled Process Engineer with hands-on experience in high-speed lines to join our client's pharmaceutical manufacturing team. This role will be focused on optimizing and supporting packaging lines and denesters, serving as the go-to technical expert for continuous...

  • Manufacturing Process Engineer

    4 weeks ago

    Holly Springs, NC, USA, United States CSL Full time

    Job Title: Manufacturing EngineerCSL Seqirus is seeking a skilled Manufacturing Engineer to join our team in Holly Springs, NC. As a key member of our production team, you will be responsible for ensuring the efficient and effective operation of our manufacturing processes.Key Responsibilities:Develop and implement process improvements to increase...

  • Manufacturing Process Specialist

    2 weeks ago

    Santa Fe Springs, California, United States Trojan Battery Company Full time

    Manufacturing Engineering TechnicianAre you passionate about working in a fast-paced manufacturing environment where innovation and collaboration thrive?We're seeking a highly skilled Manufacturing Engineering Technician to join our team at Trojan Battery Company. As a key member of our manufacturing team, you will play a critical role in ensuring the...

  • Manufacturing Support Specialist 3

    2 weeks ago

    Mount Holly Springs, Pennsylvania, United States FUJIFILM Holdings America Corporation Full time

    About This RoleThe primary function for the Manufacturing Specialist 3, Drug Product is to provide ownership to support operational readiness and sustaining operations to the Drug Product Manufacturing Inspection area.Key ResponsibilitiesProvides expertise in manual and automated visual inspection for the installation and qualification and validation of...

  • Process Analytics Associate Director

    3 months ago

    Holly Springs, United States FUJIFILM Diosynth Biotechnologies Full time

    OverviewFollow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make...

  • Process Analytics Associate Director

    3 months ago

    Holly Springs, United States FUJIFILM Diosynth Biotechnologies Full time

    OverviewFollow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make...

  • Textile Manufacturing Quality Assurance Specialist

    1 week ago

    Mount Holly Springs, Pennsylvania, United States Elevate Textiles Full time

    Job SummaryWe are seeking a skilled Textile Manufacturing Quality Assurance Specialist to join our team at Elevate Textiles. As a key member of our quality control team, you will be responsible for ensuring the highest standards of quality in our textile manufacturing process.Key ResponsibilitiesConduct quality inspections and tests on textile products to...

  • Manufacturing Process Specialist

    1 week ago

    Crescent Springs, Kentucky, United States Jabil Full time

    Job SummaryJabil is seeking a skilled Manufacturing Engineer to join our team. As a key member of our production team, you will be responsible for ensuring the quality and efficiency of our manufacturing lines.Key Responsibilities Monitor and maintain the quality of assigned manufacturing lines Develop and implement process improvements to increase...

  • Manufacturing Engineer

    4 weeks ago

    Holly Springs, Georgia, United States Fontana Full time

    Job Title: Manufacturing EngineerWe are seeking a highly skilled Manufacturing Engineer to join our team at Fontana. As a key member of our engineering department, you will play a critical role in supporting our manufacturing operations and driving process improvements.Key Responsibilities:Create, utilize, and enhance existing and/or future tooling designs...

  • Process Engineer

    1 month ago

    Holly Springs, NC , USA, United States FUJIFILM Corporation Full time

    About the RoleThis position reports to the Director of Process Engineering in support of the Process Equipment team. The successful candidate will support the Aura project, a greenfield expansion construction project in Holly Springs, NC. The initial assignment will be to assume the Responsible Engineer role for the Product Hold unit operation.As the site...

  • Manufacturing Supervisor

    3 weeks ago

    Holly Springs, United States FUJIFILM Diosynth Biotechnologies Full time

    Please note: Supervisor/Manager level candidates who have upstream manufacturing experience and API/drug substance, are highly preferred.About This RoleThis role leads a shift team and is responsible for manufacturing bulk drug substance. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours (will move to...

  • Manufacturing Supervisor

    3 weeks ago

    Holly Springs, United States FUJIFILM Diosynth Biotechnologies Full time

    Please note: Supervisor/Manager level candidates who have upstream manufacturing experience and API/drug substance, are highly preferred.About This RoleThis role leads a shift team and is responsible for manufacturing bulk drug substance. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours (will move to...

  • Process Engineer 3

    6 days ago

    Mount Holly Springs, Pennsylvania, United States FUJIFILM Corporation Full time

    Job SummaryThe Process Engineer 3 provides engineering guidance to support capital projects, technology transfer, and manufacturing operations. This role ensures compliance with all safety, regulatory, and engineering requirements, adhering to product and customer requirements, and works towards optimizing plant efficiency and profitability.Key...

  • Manufacturing Specialist

    2 weeks ago

    Diamond Springs, California, United States Dairy Farmers of America Full time

    Job Summary: We are seeking a skilled Manufacturing Specialist to join our team at Dairy Farmers of America. As a key member of our production team, you will be responsible for ensuring the efficient operation of our manufacturing processes.Key Responsibilities:Perform equipment assembly, operation, and disassembly to maintain a high level of productivity...

Specialist Manufacturing: NPI, Process Owner

3 months ago

Holly Springs, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Specialist Manufacturing: NPI, Process Owner - Facilities Lead

Live

What you will do

Lets do this. Lets change the world. In this vital role you will communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups. As part of ANCs Manufacturing Support team, this position is responsible for ensuring new products are successfully introduced into ANCs biologics manufacturing facility controls and flow of products, materials, and equipment are in compliance. It is a highly visible role across the site with the core responsibility of hosting cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility. This role will also offer the opportunity to own processes across manufacturing like gowning, and cleaning as well as participate, and lead team improvement initiatives to drive improved productivity and scheduling accuracy.

  • New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet).
  • Technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes.
  • Support Manufacturing in troubleshooting, problem solving and RCAs. Support CAPA development to prevent error recurrence.
  • Ensures that production documents are accurate and up to date.
  • Owns New Product Introduction Change Controls and collaborates with partners to drive on-time completion. Responds to regulatory questions and/or audit findings.
  • Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level.
  • Support deviation resolution and closure for facilities-related deviations with subject matter expert and quality teams, including GEMBAs.
  • Supports pre-audit corridor walkthroughs with QA and manufacturing to identify potential issues that need mitigation
  • Assist with start-up and return to service activities needed for plant shutdown.

    Win

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek has a biologics DS manufacturing background with strong multi-functional project management and communication skills as well as the below qualifications.

    Basic Qualifications:

  • High school diploma / GED & 10 years of biotechnology operations experience OR
Associates degree & 8 years of biotechnology operations experience ORBachelors degree and 4 years of biotechnology operations experience ORMasters degree 2years of biotechnology operations experience ORDoctorate degree

Preferred Qualifications:

Degree in Chemical Engineering, Industrial Engineering, Biology, or BiochemistryExcellent multi-functional project management, meeting facilitation, and technical writing skillsExperience in GMP manufacturing operationsStrong technical knowledge of drug substance processing (chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing (gowning, traffic flow, material flow, facility cleaning, etc.)Ability to coordinate, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.Ability to optimally communicate sophisticated technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing formsAbility to coach, mentor and/or cross train colleagues within core technical areasBackground in lean manufacturing methodologies and operational excellence

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.careers.amgen.com