Process Engineer
- Employer
- Novo Nordisk
- Location
- Boulder, Colorado
- Posted
- Nov 11, 2023
- Closes
- Dec 06, 2023
- Ref
- 2677263332
- Discipline
- Operations / Process
- Position Type
- Engineer
- Specialty
- Other
- Hours
- Full Time
- Organization Type
- Corporate, Other Corporate
About the Department
The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the hub for all manufacturing-related activities for GalXC and GalXC-Plus investigational therapeutics developed from Novo Nordisk's acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado facility and works closely with our teams in Lexington, Massachusetts. Ranked the No. 1 Place to Live for the second consecutive year by U.S. News & World Report, Boulder is experiencing a renaissance in biotech investment and is one of the world's leading centers for oligonucleotide innovation and manufacturing. Together, we are driving change. Are you ready to make a difference?
The Position
The Process Engineer position will support the design, build and operation of research and manufacturing facilities located in the Boulder, CO. The role is expected to be a key technical resource supporting Novo Nordisk's GALXC and GALXC+ investigational products pipeline.
Relationships
This position reports to the Director of API Manufacturing. This position interacts with manufacturing, chemical development, QC, facilities, QA and external contractors.
Essential Functions
Independently lead and support small to large sized capital engineering projects from concept design, start-up, and operation. Responsible for all phases of the project lifecycle, including the development of user requirement specifications, process design, equipment and instrumentation specification/selection, equipment procurement, installation, commissioning, qualification, and turn-over Support Chemical Development and Manufacturing with activities such as technical transfer and scale-up of manufacturing process, operation and equipment optimization, equipment trouble-shooting and continuous improvement goals Support EHS activities including chemical and hazardous assessments relating to building codes and waste management, regulatory assessments for federal, state, and local regulatory requirements for air emissions, hazardous waste generation, wastewater discharge and stormwater runoff, PHAs, PSSRs, etc. Work with internal and external resources to develop and review engineering documentation, technical standards, SOPs, protocols, risk assessments and reports Provide technical engineering support for quality activities including investigations, deviations, CAPA, change controls and gap analysis Develop, evaluate, and implement cost effective engineering solutions for equipment, facility, and utility systems Support process and automation system designs and project lifecycle activities Support equipment calibration and maintenance programs Promote a culture of safe and compliant design and operation
Physical Requirements
0-10% overnight travel required. Lifting up to 50lbs/23kg of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects.
Qualifications
Bachelor's or more advanced degree in Chemical Engineering or related technical field Minimum of three (3) years of relevant experience in the pharmaceutical, biotechnology or related industry focused on drug development and manufacturing Knowledge of pharmaceutical unit operations and equipment including chemical / API synthesis, chromatography, ultrafiltration and lyophilization is preferred Knowledge of process utility systems including; high purity water, process waste, process solvent, inert gas and glycol Knowledge of process and equipment design, controls hardware/software and strong understanding of GMPs and good engineering guidelines Knowledge with the execution of commissioning and validation activities including FAT, SAT, TOP, and IQ/OQ/PQ Ability to start-up and trouble-shoot equipment Strong technical leadership and communication skills (written and verbal), including experience presenting in front of multidisciplinary teams Experience leading projects that include managing external vendors with development, design, and testing activities Ability to provide technical leadership on multiple projects operating in parallel Experience in the transfer and scale-up of development processes to the manufacturing scale is preferred Experience with new plant startup and operations is preferred Possess excellent written and verbal communication skills Thorough understanding of cGXP and applicable regulations, ability to interpret and apply regulations to complex issues to make risk management recommendations Ability to manage people and competing priorities and timelines in a fast-paced, rapid-growth environment
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
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.
The base compensation range for this position is $65,850-$115,240.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the hub for all manufacturing-related activities for GalXC and GalXC-Plus investigational therapeutics developed from Novo Nordisk's acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado facility and works closely with our teams in Lexington, Massachusetts. Ranked the No. 1 Place to Live for the second consecutive year by U.S. News & World Report, Boulder is experiencing a renaissance in biotech investment and is one of the world's leading centers for oligonucleotide innovation and manufacturing. Together, we are driving change. Are you ready to make a difference?
The Position
The Process Engineer position will support the design, build and operation of research and manufacturing facilities located in the Boulder, CO. The role is expected to be a key technical resource supporting Novo Nordisk's GALXC and GALXC+ investigational products pipeline.
Relationships
This position reports to the Director of API Manufacturing. This position interacts with manufacturing, chemical development, QC, facilities, QA and external contractors.
Essential Functions
Physical Requirements
0-10% overnight travel required. Lifting up to 50lbs/23kg of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects.
Qualifications
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
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.
The base compensation range for this position is $65,850-$115,240.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.