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 Senior Process Engineer position will support the design, build and operation of new state of the art research and manufacturing facilities for the Novo Nordisk RNAi CMC organization. The role is expected to be a key technical resource supporting the facilities and ensure successful manufacture of starting materials and API that will support the growing number of Dicerna pre-clinical and clinical therapeutic programs.

Relationships

This position reports to the Director of API Manufacturing.

Essential Functions

• Independently lead or support assigned engineering projects from concept design through start-up
• Responsible for varying sizes of capital projects throughout 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
• Provide manufacturing and research groups technical support as needed to assist with the day-to-day manufacturing and development activities including, but not limited to new molecule introduction activities (transfer and scale-up), operation and equipment optimization, equipment, and process 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 and PSSRs
• Support equipment calibration and maintenance programs
• Work with internal and external resources to develop and review engineering documentation, technical standards, SOPs, protocols, risk assessments and reports
• Develop, evaluate, and implement cost effective engineering solutions for equipment, facility, and utility systems
• Support process and automation system designs
• Promote a culture of safe and compliant design and operation

Physical Requirements

The ability to climb, stoop, kneel, crouch, crawl, reach, stand, and walk. The ability to push, pull, lift, finger, feel, and grasp. The ability to speak, listen, and understand verbal and written communication. Repetition including substantial movement of wrists, hands, and or fingers. 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 Engineering, Chemistry or related field is required
• 6+ years of relevant work experience in engineering design, execution of capital engineering projects, and operations support in the pharmaceutical or related industry
• A working knowledge with pharmaceutical manufacturing process operations
• Knowledge and experience with process utility systems including water, solvent, waste, inert gas, glycol, and compressed air systems
• Knowledge of process and equipment design, controls hardware/software including BMS and FMS systems
• Strong understanding of GMPs and good engineering guidelines including CFR, EudraLex, GEP, ASME BPE, ASTM E2500 and ISPE guidelines
• Knowledge and experience with the execution of commissioning and validation activities including FAT, SAT, TOP, and IQ/OQ/PQ
• Direct experience and ability to start-up and trouble-shoot equipment
• The successful candidate must possess excellent writing and communication skills and a demonstrated ability to work independently and with cross-functional teams
• Ability to lead projects that include managing external vendors with development, design, and testing activities
• Ability to provide technical leadership on multiple projects operating in parallel
• Knowledge of oligonucleotide manufacturing is highly desired

In compliance with Colorado’s Equal Pay for Equal Work Act, see compensation and benefits below:

The base compensation range for this position is $90,000 to $140,000. Base compensation is determined based on a number of factors. In addition, this position is part of the Annual Performance Incentive Plan. The role may also be eligible for a long-term incentive bonus depending on level and other company factors.

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its uncapped sick time policy, flex-able vacation policy, and parental leave policy.

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.

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

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.