Senior Process Engineer

About the Department

Our Research & Development organization brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown, Cambridge and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients.

 

The Position

The Senior Process Engineer position will support the design, build and operation of research and manufacturing facilities located in Boulder, CO. The role is expected to be a key technical resource supporting Novo Nordisk's investigational products pipeline.

 

Relationships

This position reports to the Manager of Engineering. 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 required
• Minimum of five (5) years of relevant experience in the pharmaceutical, biotechnology or related industry focused on drug development and manufacturing required
• 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