Novo Nordisk
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The Deviation Leader/Coordinator is responsible for overseeing deviation investigation and CAPA management processes, fostering a learning culture, and ensuring regulatory compliance within the organization. This role involves leadership, supervision, and cross-functional collaboration to maintain quality standards and address operational deviations effectively.
Responsible for overseeing strategic processes, business partnering, finance partnering, investment controlling, and risk reporting at Novo Nordisk's manufacturing facility in West Lebanon, NH. Drive improvement initiatives, analyze financial data, prepare management reports, and lead investment project budgets. Ensure proper financial governance and risk management practices are in place.
Establish and lead a satellite team in Manufacturing Development Life Cycle Management for a pharmaceutical production site. Drive strategic activities to ensure seamless integration of new products without disrupting existing production. Maintain quality specifications, regulatory documentation, and drive a safe workplace culture. Coordinate with internal and external stakeholders to meet quality and safety requirements.
The Deviation Investigator-Writer II is responsible for investigating and writing deviations to the manufacturing process and other operational problems in API manufacturing. They lead investigations, collaborate with cross-functional teams, conduct root cause analysis, and implement corrective actions to ensure compliance with regulatory standards and quality principles. This role plays a key part in the Deviation Response Team and upholds quality priority principles within the organization.
The Manufacturing Area Specialist I position at Novo Nordisk involves supporting manufacturing operations with a focus on training, documentation, deviations, change control, and projects. Responsibilities include coordinating process and equipment improvements, reviewing quality records, generating deviation responses, driving investigations, and training technicians on processes and quality management systems. The role also involves liaising between production support and manufacturing, creating and revising documentation, conducting root cause analysis, incorporating process improvements, and supporting quality systems and Health Authority inspections.
Works closely with Laboratory personnel to support repairs, preventive maintenance & calibration of laboratory instrumentation. Responsible for activities related to BMS & alarm handling. Executes work according to schedule & department plan. Maintains training qualifications on time. Follows safety and environmental requirements in the performance of duties.
Lead a team of project management professionals in executing manufacturing suite robustness and capacity portfolio. Responsibilities include team development, project delivery, budgeting, and planning. Ensure alignment with site strategy and drive project prioritization. Communicate risks and resource constraints effectively.
This position has primary responsibility to support manufacturing operations. Focus areas may include Training, Documentation, Deviations, Change Control, and Projects. Drives the coordination and execution of process and equipment improvement programs, reviews completed quality records, generates quality deviation responses, drive investigations and has ability to train technicians on processes and QMS systems.
The IIoT Integration Engineer III is responsible for providing technical expertise and support for data and digitalization efforts. They will build and maintain infrastructure for data connectivity/flow and collaborate with cross-functional teams.
Assists with technical, quality, and project issues within the Automation team. Responsibilities include design, implementation, start-up, troubleshooting of automation and plant control systems, support for manufacturing and facilities areas, documentation, validation activities, and supervision of contractors.
As a Reliability Engineer II at Novo Nordisk, you will champion the Reliability Excellence program, drive improvements in maintenance processes, and support maintenance excellence initiatives. Responsibilities include establishing maintenance strategies, developing SOPs, managing vendor contracts, and more. Join a team that values growth and offers a range of benefits to make a meaningful impact in healthcare.
Support operations for Quality Control at a biologics manufacturing facility by assisting in process and equipment improvement programs, creating technical reports, reviewing quality records, providing training support, and more. Requires experience in Technical Writing and understanding of cGMPs and quality regulations.
The Director of Business Development at Novo Nordisk will evaluate external growth opportunities, lead negotiations, drive diligence decisions, and work closely with various teams to identify and assess deals in the R&D landscape. This role involves managing relationships with internal and external stakeholders, leading cross-functional evaluations, and making business development proposals to senior management.
Provide scientific support in protein and product characterization, process transfer, and technical support for biopharmaceutical manufacturing operations. Manage laboratory experiments, contribute to R&D teams, and ensure compliance with healthcare laws and regulations.
The QC Analyst-Microbiology position at Novo Nordisk in West Lebanon, NH, involves performing low to high complexity testing, equipment maintenance, troubleshooting, and documentation in compliance with quality regulations and guidelines. The role requires a scientific background, knowledge of laboratory practices, and the ability to follow written instructions.
Responsible for performing reviews of manufacturing and support documentation to ensure compliance with specifications and standards. Has QA signature authority on batch records. Works closely with Manufacturing and Quality Control teams to resolve issues.
Oversee and lead day-to-day QC Microbiology activities for routine testing ensuring compliance with cGMP, CFR, and SOPs. Supervise and mentor microbiology team, handle assay failures and investigations, review trending data, and ensure quality control activities align with industry standards.
Plan, manage & perform laboratory validation activities, ensure accuracy & compliance of validation & equipment records, responsible for validation of QC equipment & instrumentation, identify & handle deviations, maintain good standing with stakeholders through engagement & positive cooperation, perform & oversee change control activities for QC equipment & systems, support systematic problem solving related to equipment qualification, reviews documentation for accuracy & completeness, contribute to process confirmations, maintain training qualifications on time, follow all safety and environmental requirements.
Responsible for reviewing manufacturing and support documentation to ensure compliance with specifications and standards. Has QA signature authority on batch records and conducts internal audits. Required to work closely with manufacturing and quality control teams to resolve issues and participate in regulatory inspections. Must perform all job duties ethically and in compliance with healthcare laws.
Senior Manager - CMC Manufacturing Supply Chain responsible for developing and implementing a supply chain system, governance structures, and optimizing supply chain for cell therapy. Key role in strategic decision making and providing recommendations. Oversees internal manufacturing capacity and CMO activities, maintains supply chain dashboard, and supports planning practices.