Senior Process Engineer - API Manufacturing Leader

Biopharma Careers; Petersburg (VA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K with company match

Paid time off

Paid holidays

Life & Disability Insurance

Tuition Assistance

Job summary

The Process Engineer position at Novo Nordisk's Petersburg, VA site will support onboarding new API manufacturing programs and act as a key technical resource for new chemical API process implementation. Reports to the Associate Director, Operations and will lead projects across design, equipment and validation.

You will provide technical leadership, collaborate with cross-functional teams, support GMP compliance and drive process improvements and scale-up activities in a fast-paced

Qualifications

• Bachelor’s degree in Engineering or Chemistry from an accredited university is required.
• 8+ years of engineering experience in pharmaceutical manufacturing or related field.
• Experience with process utility systems (water, solvents, inert gas, compressed air, etc.).
• Knowledge of process and equipment design and installation.
• Familiarity with CFR, GMP, ASME BPE, ASTM E2500 and ISPE guidelines is preferred.

Responsibilities

• Lead engineering projects from concept through start-up.
• Develop user requirements, process design, equipment specs, procurement, installation, commissioning and turnover.
• Provide technical support to manufacturing and research groups for day-to-day activities including transfer and scale-up.
• Support EHS activities including PHAs and PSSRs.
• Develop and review engineering docs, SOPs, protocols, risk assessments and reports.
• Develop, evaluate and implement cost-effective engineering solutions for equipment, facilities and utilities.
• Support process and automation system designs.
• Promote safe and compliant design and operation.
• Follow safety and environmental requirements; perform other duties as assigned.

Skills

Project leadership

Cross-functional collaboration

GMP knowledge

Process troubleshooting

Documentation writing

Education

Bachelor’s degree in Engineering or Chemistry

Job description

The Process Engineer position at Novo Nordisk's Petersburg, VA site will support onboarding new API manufacturing programs and act as a key technical resource for new chemical API process implementation. Reports to the Associate Director, Operations and will lead projects across design, equipment and validation.

You will provide technical leadership, collaborate with cross-functional teams, support GMP compliance and drive process improvements and scale-up activities in a fast-paced