Novo Nordisk

Engineer

• Create & maintain system specifications for black utilities
• Support all design, installation, commissioning, qualification, training activities for black utilities
• Provide additional technical support to project team as required
• Adhere to all Quality & environmental regulations within area of responsibility
• Support technical development of Facilities Technicians after handover to LOB
• Continuous process improvement using cLEAN® concepts
• Maintain & establish standards for procedures & maintenance plans
• All safety & environmental requirements in the performance of duties

Facilities Engineer I/II - Wastewater Systems API

Analyst

• Provide subject matter expertise in Computer Systems Validation, process improvement, and IT compliance service delivery management across the site.
• Ensure that IT solutions are implemented and released to use in compliance with relevant regulations and standards facilitating the seamless transition and handover of projects to service operations with key stakeholders.
• Ensure governance and continuous improvement as an enabler supporting product quality, patient safety, and data integrity and contributes to the organization's goals of improving the lives of people with chronic diseases.
• Participate in all IT solutions validation activities including but not limited to: IT Infrastructure, IT Systems, and Computerized Equipment’s supporting Laboratories, Manufacturing, and Business Areas like Facilities and Warehousing.
• Ensure that IT solutions are compliant with relevant regulations and standards, e.g. 21 CFR Parts 11, EU Annex 11, and GAMP requirements among others.
• Facilitate, review, approve and as required develop validation deliverables including but not limited to URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ), Operating and Maintenance Instruction.
• Conduct risk assessments and impact analyses to identify potential compliance issues and develop mitigation strategies.
• Provide guidance and support to project teams on validation and qualification requirements.
• Continuously monitor and improve documentation and processes to ensure compliance with regulatory requirements and Novo Nordisk standards while working to identify efficiencies in the CSV program approach, applying lessons learned, and stay informed of industry regulatory changes as it applies to CSV.
• Perform assigned Quality Systems activities including Document Management system, Change Control, Deviations, and CAPA’s Writing and/or revising procedures applicable to CSV activities.
• Work in collaboration with the Engineering group to prepare the validation, requalification, and maintenance program.
• Facilitate the seamless transition and handover of projects to service operations with key stakeholders.
• Maintain system documentation and process according to Novo Nordisk standards and in compliance with regulatory requirements.
• Participate as a CSV SME in audits and inspections and provide needed documentation to demonstrate validated state and release to use.
• Collaborate with cross-functional teams to ensure that all IT solutions meet business needs, are delivered on time & within budget, and are properly documented and released to use.
• Ensure that all documentation and processes are following regulatory requirements and Novo Nordisk standards.
• Provide leadership and expertise in IT CSV, process improvement, and project coordination.
• Coach and mentor personnel, and provide guidance as needed.
• Participate in process group meetings and contribute to process group activities.
• Execute project activities and process improvement by incorporating cLEAN tools for visual management to track service delivery performance and communicate progress to stakeholders.
• Utilize problem solving skills to handle deviations to ensure they are properly documented, investigated, and resolved in a timely manner, as well as ensuring subsequent changes are properly documented, assessed for impact, and implemented in a controlled manner.
• Develop and deliver training programs for CSV and process improvement initiatives.
• Communicate effectively with stakeholders at various levels of the organization to ensure that CSV issues, improvement opportunities, and service delivery meet business needs and are aligned with regulatory requirements and Novo Nordisk standards.
• Moreover, will also perform other duties as assigned.
• Follow all safety & environmental requirements in the performance of duties.

Senior Computer Systems Validation Analyst

Compliance

• Provide subject matter expertise in IT compliance, process improvement and IT compliance service delivery management across the site
• Ensures that IT solutions are compliant with relevant regulations and standards and facilitates the seamless transition and handover of projects to service operations with key stakeholders
• Ensures governance and continuous improvement as an enabler supporting product quality, patient safety, and data integrity and contributes to the organization's goals of improving the lives of people with chronic diseases
• Develop and maintain validation and qualification documentation
• Conduct risk assessments and impact analyses to identify potential compliance issues and develop mitigation strategies
• Provide guidance and support to project teams on validation and qualification requirements
• Continuously monitor and improve documentation and processes to ensure compliance with regulatory requirements and Novo Nordisk standards
• Facilitate the seamless transition and handover of projects to service operations with key stakeholders
• Maintain system documentation and process according to Novo Nordisk standards and in compliance with regulatory requirements
• Participate as an IT SME in audits and inspections and provide needed documentation to demonstrate validated state and proper management of IT solutions throughout the life cycle
• Collaborate with cross-functional teams to ensure that all IT solutions meet business needs, are delivered on time & within budget, are properly documented, and managed throughout their life cycle
• Ensure that all IT solutions, documentation, and processes are following regulatory requirements and Novo Nordisk standards
• Provide leadership and expertise in IT compliance, process improvement, and project coordination
• Coach and mentor personnel, and provide guidance as needed
• Participate in process group meetings and contribute to process group activities
• Follow all safety & environmental requirements in the performance of duties

Senior IT Compliance Analyst

Director

• Set strategic direction and lead the execution of comprehensive Total Rewards solutions
• Combine strategic insight, data-driven decision-making and strong stakeholder collaboration
• Lead a global team of 11 Total Rewards professionals supporting Europe (excluding HQ), Canada and Emerging Markets
• Use internal and external market data to design competitive, compliant and scalable reward solutions aligned with business strategy
• Partner with senior leaders, HRBPs and Total Rewards HQ teams
• Develop team capability through knowledge sharing, coaching and a strong focus on continuous improvement

Director, Global Total Rewards

Vice President

• Lead the Global Public Affairs department through transformation
• Set and drive the global public affairs strategy and priorities
• Establish governance for public affairs standards
• Serve as the escalation point for public affairs issues
• Represent Novo Nordisk as a trusted external leader
• Mentor and enable public affairs leaders across the organization

Vice President, Global Public Affairs

• Be accountable for and lead end-to-end regulatory submission activities for cross-product, cross-site, and manufacturing facility/equipment change projects.
• Contribute to new product submissions by leading regulatory strategies and activities related to manufacturing facilities and equipment.
• Coordinate activities related to the creation and maintenance of dossier documentation for manufacturing facilities, manufacturing equipment, and associated processes (such as cleaning validation, sterilisation, environmental monitoring, media-fill etc).
• Demonstrate strong leadership by setting the strategic regulatory direction for projects.
• Acting as an RA Site Partner by fostering close collaboration with manufacturing sites to proactively align on planned site-level changes.

Regulatory Affairs Specialist – RA Manufacturing Facilities, Projects

Mechanical Engineer

• Generating ideas and designing mechanical solutions for advanced aseptic production systems
• Creating 2D and 3D models using CAD software
• Testing and prototyping solutions, including hands-on work with 3D printing
• Contributing to solutions that are implemented in production sites around the world (Denmark, China, Brazil, France, and the US)
• Collaborating with academics, technicians and external development partners across different disciplines and countries

Mechanical Engineer Intern

• Support selected projects and products in the Novo Nordisk portfolio
• Provide strategic and scientific input to support development
• Secure regulatory approvals, and ensure compliance with evolving global regulations
• Lead and drive strategic regulatory device activities for drug-device combination products
• Plan, prepare, and lead health authority interactions and meetings
• Identify regulatory risks and opportunities, and provide clear recommendations

Regulatory Affairs Specialist – Device

• Formulate, Negotiate & Scale Strategic eHealth Partnerships: Commercial Integration Strategy: Actively shape and execute APAC’s direct-to-patient commercial strategy to achieve our regional volume through eHealth channels.
• Complex Deal Architecture: Lead end-to-end negotiation, customized commercial structuring, and deal closure with Tier 1 partners and digital disruptors.
• Portfolio Lifecycle Scaling: Design plug-and-play partnership frameworks to rapidly scale validated commercial models across growth markets.
• Cross-Functional Influence & Regional Network Governance: Serve as the primary regional connector across affiliates to align local general managers, business unit heads behind a shared digital roadmap.
• Data Infrastructure, Funnel Visibility & Optimization: Secure deep-tier API and data-sharing agreements with platform partners to stream certified analytics into our regional repository.
• Strategic GTM & Business Intelligence: Conduct market assessments to understand digital maturity, platform dynamics, and competitive behaviours across APAC.
• AI & Next-Gen Innovation Scouting: Evaluate emerging digital health trends to build defensible business cases and present investment recommendations to executive leadership.
• Commercial and financial modelling: Lead commercial and financial modelling to support digital and eHealth partnership strategy across APAC.

Associate e-Health Channel Director

• Provide routine support & troubleshooting for the manufacturing facility.
• Primary tasks: provide input, review & approve design & requirement documents; provide input, review & approve technical specifications.
• Support development of design & requirement specifications documents
• Support quality of equipment & processes
• Support the creation of process tracks risk assessment documents, such as Requirement Risk Assessments (RRA’s)
• Participation in the creation of a project cGMP Statement
• Create & participate in Quality Risk Management (QRM) risk assessments, such as Closed-Process, Cross-Contamination, Contamination & Facility flows
• Own self development and partner with manager for clear understanding of development needs for desired career path
• Input & review to Process FMECA’s for the Process tracks
• Participation in design workshops with engineering suppliers
• Input & review of Process Module Diagrams, & Process Flow Diagrams
• Input & review of Process Scheduling & Capacity Calculations
• Support package in maintaining schedule adherence
• Ensure coordination & collaboration between project & other site stakeholders
• Gather & ensure knowledge transfer to project from DK sponsor site
• Follow all safety & environmental requirements in the performance of duties
• Other duties as assigned

Associate Process Engineer – API

• Ensure evaluation, prioritisation, implementation, communication, and training in new Veeva RIM features across Regulatory Affairs
• Support and drive Veeva RIM process development and optimisation
• Engage with stakeholders and external vendors, providing technical guidance and regulatory input to ensure fit-for-purpose processes and solutions
• Guarantee alignment with external regulatory requirements

Regulatory Professional – Veeva RIM

• formulate, negotiate & scale strategic eHealth partnerships
• lead end-to-end negotiation, customized commercial structuring, and deal closure with Tier 1 partners and digital disruptors
• design plug-and-play partnership frameworks to rapidly scale validated commercial models across growth markets
• deepen collaboration with existing eHealth and online‑selling partners
• serve as the primary regional connector across affiliates
• champion the integration of global clinical milestones into non-branded partner educational pathways
• lead advanced capability-building sessions, cross-market strategy workshops, and digital maturity standardizations
• secure deep-tier API and data-sharing agreements with platform partners
• leverage advanced analytics dashboards to actively audit consumer experiences
• conduct market assessments to understand digital maturity, platform dynamics, and competitive behaviours across APAC

Associate Director – e-Health Channel

• The purpose of this position is to maintain Utility systems for the API-US facility.
• Responsibilities include, but are not limited to: writing/reviewing specifications; design reviews; equipment installation; commissioning & qualifications; SOP development; maintenance development & training; management of cost, quality issues; schedule; establishing & maintaining positive working relationship with internal & external engineering team & stakeholders; re-validation, management of vendor & service contracts ensuring all activities are aligned with Environmental Health & Safety (EHS) program requirements.
• Train on systems, processes & related equipment
• Learn to create & maintain system specifications
• Support all design, installation, commissioning, qualification & training activities
• Provide additional technical support to team & project team as required
• Adhere to all Quality & Environmental regulations within area of responsibility
• Continuous process improvement on department owned systems using cLEAN® concepts
• Assist in developing & writing standards, procedures & maintenance plans
• All safety & environmental requirements in the performance of duties

Facilities Engineer – Utilities – Associate

Regulatory Professional

General Counsel

• Advise and support the Global Manufacturing & Supply organisation
• Assist and support on complex high-value matters
• Identify and assess critical legal issues
• Collaborate with senior stakeholders to guide decision-making
• Drive ad hoc projects focused on optimizing the way of working