Senior API Process Engineer: Lead New API Scale-Up

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

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.