Senior Process Engineer - API manufacturing

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API development and production, strengthening and accelerating our Small Molecule (SMOL) strategy while amplifying operational capacity.

About the role

The Process Engineer will support the site to onboard new API manufacturing programs and serve as a key technical resource for new chemical API process implementation.

Responsibilities

• Independently lead or support assigned engineering projects from concept design through start-up.
• Provide input on varying sizes of capital projects throughout all phases of the project lifecycle, including development of user requirement specifications, process design, equipment and instrumentation specification/selection, procurement, installation, commissioning/qualification, and turn-over.
• Provide technical support to manufacturing and research groups for day-to-day activities, including new molecule introduction (transfer and scale-up), operation and equipment optimization, troubleshooting, and continuous improvement.
• Support EHS activities, including chemical and hazardous assessments, PHAs, and PSSRs.
• 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.
• Perform other duties as assigned.

Requirements

Physical Requirements

• Move equipment/supplies weighing up to 33 pounds within the facility using various body positions.
• Routinely operate and inspect manufacturing equipment using hands.
• Strap and unstrap pallets using hands.
• Stand for up to a 12-hour shift.
• May require corrected vision to 20/20 or 20/25 and color vision based on role.
• Occasionally ascend/descend a ladder and work at elevated heights.
• Occasionally work around odorous and/or hazardous materials.
• May be required to wear latex gloves.
• May perform critical job functions in extremely cold work environments.
• May position oneself within confined spaces for inspection.
• Ability to work in loud noise environments with hearing protection.
• May be required to secure a motorized vehicle license and operate a motorized vehicle.

Qualifications

• Bachelor’s degree in Engineering or Chemistry from an accredited university.
• Minimum of eight (8) years of relevant work experience, including engineering processes & design and operations support, preferably in a pharmaceutical manufacturing environment.
• Knowledge and experience with two (2) or more of the following: process utility systems including water, solvent, waste, inert gas, glycol, syltherm, and compressed air systems.
• Strong understanding of engineering guidelines (e.g., CFR, GEP, ASME BPE, ASTM E2500, ISPE guidelines).
• Direct experience starting up and troubleshooting equipment.
• Excellent writing and communication skills; ability to work independently and with cross-functional teams.
• Ability to lead projects, manage external vendors, and provide technical leadership on multiple parallel projects.
• Strong understanding of Good Manufacturing Practices (GMPs) is a plus.
• Experience with capital engineering projects and pharmaceutical manufacturing process operations is preferred.
• Knowledge and experience with commissioning and validation activities (FAT, SAT, TOP, IQ/OQ/PQ) is a plus.

Benefits

• Leading pay and annual performance bonus for all positions.
• Generous paid time off, including 14 paid holidays.
• Health, dental, and vision insurance effective day one.
• Guaranteed 8% 401K contribution plus individual company match option.
• Family-focused benefits: 14 weeks paid parental leave and 6 weeks paid family medical leave.
• Free access to Novo Nordisk-marketed pharmaceutical products.
• Tuition assistance.
• Life and disability insurance.
• Employee referral awards.