Novo Nordisk
About the Department
At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.
Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.
What we offer you:
Leading pay and annual performance bonus for all positions
All employees enjoy generous paid time off including 14 paid holidays
Health Insurance, Dental Insurance, Vision Insurance - effective day one
Guaranteed 8% 401K contribution plus individual company match option
Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
Free access to Novo Nordisk-marketed pharmaceutical products
Tuition Assistance
Life & Disability Insurance
Employee Referral Awards
At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
The Position
The Engineer will support ongoing activities by assisting in troubleshooting mechanical problems, identifying improvements in utilities to minimize interruptions (down time) and reduce energy usage/cost, and supporting new and ongoing projects. This position will further assist in the management and planning of project budgets and schedules and provide contractor oversight. This position will assist in identifying, tracking, forecasting, and implementing capital expenditure projects by working with site leadership and departmental end users to identify the correct project parameters and utility requirements. The Engineer may establish new Standard Operating Procedures (SOPs) and/or recommend changes to current SOPs based on facility needs. This person will work on complex facility-related problems requiring in-depth data analysis to determine appropriate action. The Engineer is expected to have extensive ongoing communication with employees and cross-functional group managers/departments on facility-related issues.
Relationships
Reports to Supervisor.
Essential Functions
Support the multi-use facility, including HVAC systems and bio-containment systems
Support selection and installation of manufacturing equipment
Proactively and effectively partner with the facility commissioning/validation team, including operational protocol development, to implement compliance with FDA GMP requirements
Draft SOPs for building operation, maintenance, and calibration
Identify improvements and efficiencies of facility preventative maintenance
Provide engineering guidance and execution on facilities and equipment projects
Perform hands-on activities as needed to help troubleshoot facility problems and support facility staff
Develop standard processes to evaluate future capital projects
Drive continuity and development of standards in Project Engineering to ensure smooth and effective communication flow between internal resources and customers, operational efficiency, and equipment and personnel safety
Create and maintain all aspects of equipment design files
Maintain project compliance in accordance with the site quality management system
Guide the specification and selection of manufacturing/utility equipment to support site facility/ process needs
Monitor, maintain, and repair existing production and laboratory control and monitoring systems (PLC, sub-networks, software, etc.)
Apply and enhance existing automation validation programs for the validation of new and existing production and laboratory automated systems, including major capital projects and continuous improvement of systems
Draft, review, execute, and approve protocols and reports related to Automation System Validation (CSV). This includes deviation reporting during execution
Act as primary Subject Matter Expert (SME) for CSV
Assist and manage production and laboratory system contractors as required
Review and approve changes to computerized automation production and laboratory systems through the change control program to assess impact on validated systems
Assist in responding to customer/regulatory audit observations and corrective actions as it pertains to automation system validation
Identify and implement improvement opportunities for established production systems
Collaborate significantly with cross functional groups including Validation, Quality Control, Manufacturing, Process Development, and Facilities
Support local and global IT
Manage software and hardware support agreements to ensure compliance and minimize cost impact. Manage third party contractors who may work on Company systems
Provide technical assistance and training for personnel
File and maintain controlled documents
Complete knowledge of varied aspects or a single specialized aspect of a discipline and some knowledge of principles and concepts in other disciplines
Apply technical and functional knowledge to conduct experiments/research in assigned area
May act as a technical resource within own work group/project team
Work independently to solve problems of moderate scope
Actively participate and suggest solutions to problems
Follow all safety and environmental requirements in the performance of duties
Other duties as assigned
Physical Requirements
Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 30 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be heating ventilation and air condition controlled. Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning. May be exposed to inclement weather or be required to work in environments or under conditions that require the use of protective gear and/or awareness of personal safety and safety of others.
Qualifications
Bachelor's degree in Chemical/Mechanical/Electrical Engineering or appropriate scientific discipline, required, or 8 years of engineering experience in lieu of the degree
PE / Registered Engineer in training, preferred
OSHA 10 or equivalent a plus, preferred
2+ years of Project Engineering related experience
Technical Requirements
Ability to use Excel, Word, and other office systems
Ability to formulate complex and comprehensive materials such as authoritative reports and/or to create/deliver formal and informal presentations
Ability to cross-train on techniques across multiple groups
Ability to independently interpret data, analyze trends, and provide insight into potential issues and subsequent solutions
Ability to complete investigation, deviation, and change control forms independently
Proficient in operation and troubleshooting of a wide variety of instrumentation and data systems
Ability to provide ideas, introduce new technology, and drive process improvements. Work with other groups to develop, qualify, and transfer methods accordingly
Understanding and adherence to applicable regulatory authority and guidelines
Write, edit, and review SOPs
Exposure to contractual management and processes
Problem-solving (Lean Six Sigma) and change management methodologies consistent with establishing a culture of continuous improvement is preferred
Team leadership and project-management skills
Understanding of proposal and project scope as it relates to pricing, resources management, and the impact on business
Ability to operate within a clean room environment
Behavioral Requirements
Ability to see and hear, read, and write clear English
Requires adaptability, analyzing, assessing, calculating, decision making, dependability, good judgment, reading, memorizing, social skills, speaking, stress control, writing
Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate manner
Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time
Ability to cooperate with coworkers within an organized team environment or work alone
Detail oriented with ability to work effectively under high pressure with multiple deadlines
Strong ability to multi-task in a fast-paced environment
Positive attitude and ability to work with others
Ability to process a large volume of work
Ability to effectively carry out and implement change
Ability to put aside personal opinions and focus on business needs, department needs, or group needs
Leadership Requirements
Ability to organize and prioritize work schedules of others on short and long-term basis, including integrating timelines and meeting milestones for successful project completion
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.
Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.
What we offer you:
Leading pay and annual performance bonus for all positions
All employees enjoy generous paid time off including 14 paid holidays
Health Insurance, Dental Insurance, Vision Insurance - effective day one
Guaranteed 8% 401K contribution plus individual company match option
Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
Free access to Novo Nordisk-marketed pharmaceutical products
Tuition Assistance
Life & Disability Insurance
Employee Referral Awards
At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
The Position
The Engineer will support ongoing activities by assisting in troubleshooting mechanical problems, identifying improvements in utilities to minimize interruptions (down time) and reduce energy usage/cost, and supporting new and ongoing projects. This position will further assist in the management and planning of project budgets and schedules and provide contractor oversight. This position will assist in identifying, tracking, forecasting, and implementing capital expenditure projects by working with site leadership and departmental end users to identify the correct project parameters and utility requirements. The Engineer may establish new Standard Operating Procedures (SOPs) and/or recommend changes to current SOPs based on facility needs. This person will work on complex facility-related problems requiring in-depth data analysis to determine appropriate action. The Engineer is expected to have extensive ongoing communication with employees and cross-functional group managers/departments on facility-related issues.
Relationships
Reports to Supervisor.
Essential Functions
Support the multi-use facility, including HVAC systems and bio-containment systems
Support selection and installation of manufacturing equipment
Proactively and effectively partner with the facility commissioning/validation team, including operational protocol development, to implement compliance with FDA GMP requirements
Draft SOPs for building operation, maintenance, and calibration
Identify improvements and efficiencies of facility preventative maintenance
Provide engineering guidance and execution on facilities and equipment projects
Perform hands-on activities as needed to help troubleshoot facility problems and support facility staff
Develop standard processes to evaluate future capital projects
Drive continuity and development of standards in Project Engineering to ensure smooth and effective communication flow between internal resources and customers, operational efficiency, and equipment and personnel safety
Create and maintain all aspects of equipment design files
Maintain project compliance in accordance with the site quality management system
Guide the specification and selection of manufacturing/utility equipment to support site facility/ process needs
Monitor, maintain, and repair existing production and laboratory control and monitoring systems (PLC, sub-networks, software, etc.)
Apply and enhance existing automation validation programs for the validation of new and existing production and laboratory automated systems, including major capital projects and continuous improvement of systems
Draft, review, execute, and approve protocols and reports related to Automation System Validation (CSV). This includes deviation reporting during execution
Act as primary Subject Matter Expert (SME) for CSV
Assist and manage production and laboratory system contractors as required
Review and approve changes to computerized automation production and laboratory systems through the change control program to assess impact on validated systems
Assist in responding to customer/regulatory audit observations and corrective actions as it pertains to automation system validation
Identify and implement improvement opportunities for established production systems
Collaborate significantly with cross functional groups including Validation, Quality Control, Manufacturing, Process Development, and Facilities
Support local and global IT
Manage software and hardware support agreements to ensure compliance and minimize cost impact. Manage third party contractors who may work on Company systems
Provide technical assistance and training for personnel
File and maintain controlled documents
Complete knowledge of varied aspects or a single specialized aspect of a discipline and some knowledge of principles and concepts in other disciplines
Apply technical and functional knowledge to conduct experiments/research in assigned area
May act as a technical resource within own work group/project team
Work independently to solve problems of moderate scope
Actively participate and suggest solutions to problems
Follow all safety and environmental requirements in the performance of duties
Other duties as assigned
Physical Requirements
Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 30 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be heating ventilation and air condition controlled. Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning. May be exposed to inclement weather or be required to work in environments or under conditions that require the use of protective gear and/or awareness of personal safety and safety of others.
Qualifications
Bachelor's degree in Chemical/Mechanical/Electrical Engineering or appropriate scientific discipline, required, or 8 years of engineering experience in lieu of the degree
PE / Registered Engineer in training, preferred
OSHA 10 or equivalent a plus, preferred
2+ years of Project Engineering related experience
Technical Requirements
Ability to use Excel, Word, and other office systems
Ability to formulate complex and comprehensive materials such as authoritative reports and/or to create/deliver formal and informal presentations
Ability to cross-train on techniques across multiple groups
Ability to independently interpret data, analyze trends, and provide insight into potential issues and subsequent solutions
Ability to complete investigation, deviation, and change control forms independently
Proficient in operation and troubleshooting of a wide variety of instrumentation and data systems
Ability to provide ideas, introduce new technology, and drive process improvements. Work with other groups to develop, qualify, and transfer methods accordingly
Understanding and adherence to applicable regulatory authority and guidelines
Write, edit, and review SOPs
Exposure to contractual management and processes
Problem-solving (Lean Six Sigma) and change management methodologies consistent with establishing a culture of continuous improvement is preferred
Team leadership and project-management skills
Understanding of proposal and project scope as it relates to pricing, resources management, and the impact on business
Ability to operate within a clean room environment
Behavioral Requirements
Ability to see and hear, read, and write clear English
Requires adaptability, analyzing, assessing, calculating, decision making, dependability, good judgment, reading, memorizing, social skills, speaking, stress control, writing
Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate manner
Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time
Ability to cooperate with coworkers within an organized team environment or work alone
Detail oriented with ability to work effectively under high pressure with multiple deadlines
Strong ability to multi-task in a fast-paced environment
Positive attitude and ability to work with others
Ability to process a large volume of work
Ability to effectively carry out and implement change
Ability to put aside personal opinions and focus on business needs, department needs, or group needs
Leadership Requirements
Ability to organize and prioritize work schedules of others on short and long-term basis, including integrating timelines and meeting milestones for successful project completion
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.