Senior Process Engineer - API manufacturing

Initial Therapeutics, Inc.; Petersburg (VA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Annual bonus

Paid holidays

Health insurance

401K match

Parental leave

Tuition assistance

Life & disability

Referral awards

Job summary

Novo Nordisk is seeking a seasoned Process Engineer to support the Petersburg, VA API manufacturing program. You will lead process design, scale-up, and equipment qualification for new chemical API projects, ensuring GMP compliance and safe operations.

You will collaborate with R&D, manufacturing, and external vendors to deliver robust processes, optimize utilities, and drive continuous improvement while upholding regulatory requirements and quality standards.

Qualifications

• Bachelor’s degree in an Engineering or Chemistry field required.
• Minimum of eight (8) years of relevant experience in pharmaceutical manufacturing environment.
• Experience with process utility systems including water, solvent, waste, inert gas, glycol, syltherm and compressed air.
• Strong understanding of CFR, GEP, ASME BPE, ASTM E2500 and ISPE guidelines.
• Direct experience and ability to start-up and trouble-shoot equipment required.
• Ability to lead projects that include managing external vendors with development, design and testing activities is required.

Responsibilities

• Lead or support engineering projects from concept through start-up.
• Develop user requirements, process design, equipment specs, and procurement.
• Provide manufacturing and R&D technical support for day-to-day activities.
• Support EHS activities including chemical hazard assessments (PHAs/PSSRs).
• Review engineering documentation, SOPs, protocols, risk assessments and reports.
• Develop, evaluate and implement cost-effective engineering solutions for systems.
• Support process and automation system designs and compliance.
• Promote safe and compliant design and operation.
• Follow safety and environmental requirements in performance of duties.

Skills

Process engineering

Project leadership

Vendor management

Cross-functional collaboration

Technical writing

Education

Bachelor's degree in Engineering or Chemistry

Tools

GMP guidelines

FAT/SAT/IQ/OQ/PQ

ISPE standards

Job description

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. Being part of Novo Nordisk allows our employees to embark on 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 positionsAll employees enjoy generous paid time off including 14 paid holidaysHealth Insurance, Dental Insurance, Vision Insurance – effective day oneGuaranteed 8% 401K contribution plus individual company match optionFamily Focused Benefits including 14weeks paid parental & 6 weeks paid family medical leaveFree access to Novo Nordisk-marketed pharmaceutical productsTuition AssistanceLife & Disability InsuranceEmployee 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 Associate Director, Operations

Essential Functions

• Independently lead or support assigned engineering projects from concept design through start-upResponsible 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-overProvide 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 goalsSupport EHS activities including chemical and hazardous assessments including participation in PHAs and PSSRsWork with internal and external resources to develop and review engineering documentation, technical standards, SOPs, protocols, risk assessments and reportsDevelop, evaluate and implement cost effective engineering solutions for equipment, facility and utility systemsSupport process and automation system designsPromote a culture of safe and compliant design and operationFollow all safety and environmental requirements in the performance of dutiesOther 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 colour 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 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 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

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

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.