3 часа назад
Project Engineer (Biotech Focus)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Project Engineer (Biotech Focus) (GMP Bioproduction): Supporting and leading manufacturing projects, process improvements, equipment changes, and complex investigations in an onsite GMP bioproduction facility with an accent on automation, validation, compliance, and capacity improvement. Focus on troubleshooting deviations, coordinating contractors and vendors, managing project budgets and timelines, and maintaining validated systems under FDA and EU requirements.
Location: Onsite five days a week at the West Lebanon, NH bioproduction facility, United States
Company
Novo Nordisk develops and manufactures treatments for serious chronic diseases, including hemophilia, growth hormone, and next-generation healthcare products.
What you will do
- Support and lead capital, operational excellence, process improvement, and capacity expansion projects in a GMP bioproduction facility.
- Troubleshoot manufacturing processes and equipment, support deviation investigations, and define corrective actions.
- Develop and implement procedural and automation improvements while maintaining validated systems.
- Participate in design and hazard reviews and act as the technical contact for contractor design, fabrication, installation, and validation activities.
- Manage project scope, budgets, risk assessments, cost estimates, purchase requisitions, timelines, and payment schedules.
- Prepare and review protocols, validation documentation, summary reports, and trend reports while coordinating activities with vendors and cross-functional teams.
Requirements
- Bachelor’s degree in engineering or a related discipline required; a master’s degree is preferred.
- Five years of related experience with a bachelor’s degree required, or three years with a master’s degree preferred.
- Knowledge of automation, GMP, compliance, and regulatory requirements, including FDA and EU standards.
- Ability to work in a fast-paced, team-oriented manufacturing environment with strong communication skills.
- Availability for on-call rotations, including weekends and non-business hours, with the ability to respond within 60 minutes.
- Ability to perform physical manufacturing-site activities, including climbing, standing, walking, reaching, and lifting up to 33 lb occasionally.
Nice to have
- Master’s degree in engineering or a related discipline.
- Medium- to large-scale pharmaceutical or biotechnology process experience.
Culture & Benefits
- Work in a supportive, patient-focused manufacturing community with a strong emphasis on ethics and quality.
- Access to career development opportunities, resources, and mentorship.
- Collaborate with cross-functional teams, external vendors, contractors, and interns.
- Participate in an inclusive recruitment process with equal employment opportunity.
- Local and international travel expected at 0–10%.
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