Senior Process Engineer - API manufacturing

Novo Nordisk•Petersburg, VA

About The Position

The Process Engineer position will support the site to onboard new API manufacturing programs. In addition, the role is expected to be a key technical resource supporting new chemical API process implementation. Novo Nordisk's new Petersburg, Virginia site marks a strategic move to advance capabilities in Emerging Technologies (ET) within Chemical API development and production. The highly experienced site is designed to strengthen and accelerate the Small Molecule (SMOL) strategy while amplifying operational capacity. This is to safeguard and support ET's SMOL projects in the coming years, aligning with the vision and strengthening potential for growth and innovation.

Requirements

Bachelor’s degree in an Engineering or Chemistry field of study from an accredited university required
Minimum of eight (8) years of relevant work experience to include engineering processes & design and operations support required, preferably in a pharmaceutical manufacturing environment
Knowledge and experience with two (2) or more of the following required: process utility systems including water, solvent, waste, inert gas, glycol, syltherm and compressed air systems
Knowledge of process and equipment design and installation required
Strong understanding of engineering guidelines to include one or more of the following required: CFR, GEP, ASME BPE, ASTM E2500 and ISPE guidelines
Direct experience and ability to start-up and trouble-shoot equipment required
Possess excellent writing and communication skills and a demonstrated ability to work independently and with cross-functional teams required
Ability to lead projects that include managing external vendors with development, design and testing activities is required
Ability to provide technical leadership on multiple projects operating in parallel required
Strong understanding of Good Manufacturing Practices (GMPs) a plus

Nice To Haves

Experience working with capital engineering projects is preferred
A working knowledge with pharmaceutical manufacturing process operations is preferred
Knowledge and experience with the execution of commissioning and validation activities including FAT, SAT, TOP and IQ/OQ/PQ a plus

Responsibilities

Independently lead or support assigned engineering projects from concept design through start-up
Responsible for providing input on 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 including participation in PHAs and PSSRs
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
Follow all safety and environmental requirements in the performance of duties
Other duties as assigned