7 дней назад
Project Engineer (Biopharma)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Project Engineer (Biopharma): Leading the technical definition, design, and delivery of facility, utility, and equipment projects in a cGMP manufacturing environment with an accent on engineering specifications, design reviews, compliance, and lifecycle readiness. Focus on translating complex operational requirements into practical solutions, managing technical risks and quality records, and solving project or system issues through structured troubleshooting and root cause analysis.
Location: Hoofddorp, Netherlands; onsite with hybrid eligibility
Company
is a biopharmaceutical company developing CAR T-cell and T-cell receptor therapies for cancer treatment.
What you will do
- Lead the technical definition, design, and delivery of facility, utility, and equipment projects.
- Translate business needs, user requirements, and operational constraints into engineering concepts, scopes, and technical solutions.
- Lead feasibility studies, option assessments, technical specifications, tender packages, and scopes of work.
- Review engineering designs, calculations, drawings, specifications, and vendor deliverables for compatibility, compliance, and quality.
- Manage technical input for change controls, risk assessments, deviations, CAPA actions, and other project quality records.
- Monitor contractor execution, maintain controlled engineering documentation, and lead troubleshooting and root cause analysis.
Requirements
- Bachelor’s degree in Engineering, Technology, or a related technical discipline.
- At least 6 years of relevant engineering experience in a cGMP commercial manufacturing environment or another highly regulated industry.
- Experience leading the technical design and delivery of facility, utility, or equipment projects.
- Experience with engineering specifications, feasibility studies, design packages, tender documentation, and vendor deliverables.
- Knowledge of cGMP manufacturing, engineering change management, risk management, deviations, CAPA, regulatory requirements, qualification, handover, and operational readiness.
- Strong troubleshooting, structured problem-solving, technical communication, prioritization, and stakeholder-management skills.
Nice to have
- Experience with AutoCAD or Revit.
- Experience working with external design partners.
Culture & Benefits
- Work in a mission-driven biopharmaceutical environment focused on developing cancer immunotherapies.
- Hybrid eligibility within an onsite project engineering role.
- Contribute to engineering standards, templates, lessons learned, and knowledge sharing across the Kite network.
- Work in an environment emphasizing inclusion, development, empowerment, and cross-functional collaboration.
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