Senior Process Engineer - API Manufacturing

Novo Nordisk A/S; Petersburg (VA); On-site; USD 80,000 - 120,000; Full time

Job summary

Join a forward-thinking company as a Senior Process Engineer in API Manufacturing, where you will lead innovative projects that enhance the quality of life for millions. This role involves supporting new chemical API processes, managing engineering projects, and ensuring compliance with industry standards. With a commitment to employee growth and inclusivity, this organization offers a dynamic work environment and opportunities for professional development. Be part of a team that values diverse perspectives and strives to make a meaningful impact in the pharmaceutical industry.

Benefits

Generous Paid Time Off

Health, Dental, and Vision Insurance

401K Contribution

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Qualifications

• 8+ years of experience in engineering processes and design in pharmaceutical manufacturing.
• Strong understanding of GMPs and engineering guidelines.
• Ability to lead projects and manage external vendors.

Responsibilities

• Lead engineering projects from concept design through start-up.
• Provide technical support for manufacturing and development activities.
• Ensure compliance with safety and environmental requirements.

Skills

Engineering Processes

Process Design

Operations Support

Communication Skills

Project Management

Education

Bachelor's Degree in Engineering or Chemistry

Tools

GMP Guidelines

Commissioning and Validation Activities

Process Utility Systems

Job description

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Senior Process Engineer - API Manufacturing

Location:

Petersburg, VA, US

About the Department

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. Beingpart of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API development and production. The highly experienced site is designed to strengthen and accelerate our Small Molecule (SMOL) strategy while amplifying our operational capacity. This is to safeguard and support ET´s SMOL projects in the coming years, aligning with our vision and strengthening our potential for growth and innovation.

What we offer you:

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 14weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

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.

Relationships

Reports to Manager.

Essential Functions

• 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

Physical Requirements

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role.

Qualifications

• 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
• Experience working with capital engineering projects is preferred
• A working knowledge with pharmaceutical manufacturing process operations is preferred
• 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 Good Manufacturing Practices (GMPs) a plus
• Strong understanding of engineering guidelines to include one or more of the following required: CFR, 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 a plus
• 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

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.

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.