Senior Process Engineer

Novo Nordisk • Boulder, CO

1d

About 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.

Requirements

• 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 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

Nice To Haves

• Knowledge of pharmaceutical unit operations and equipment including chemical / API synthesis, chromatography, ultrafiltration and lyophilization is preferred
• 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

Responsibilities

• 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

Benefits

• Novo Nordisk offers long-term incentive compensation and/or company vehicles depending on the position's level or 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 sick time policy, flex-able vacation policy, and parental leave policy.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees