14 часов назад
Director Engineering (Biotechnology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director, Engineering (Biotechnology): Leading engineering, automation, maintenance, and instrumentation capabilities for a GMP drug-substance manufacturing facility with an accent on asset reliability, regulatory compliance, and operational continuity. Focus on building a high-performing technical organization, managing complex maintenance and capital programs, and driving data-based reliability and sustainability improvements.
Location: Holly Springs, North Carolina, United States; onsite role
Company
is a biotechnology company developing, manufacturing, and delivering medicines to patients worldwide.
What you will do
- Lead the Engineering, Automation, Maintenance, and Instrumentation functions supporting drug-substance manufacturing operations.
- Set and execute the long-term technical and organizational strategy for a complex GMP manufacturing site.
- Manage asset reliability programs covering preventive and predictive maintenance, calibration, spare parts, and lifecycle management.
- Maintain engineering compliance and inspection readiness across cGMP, EHS, quality systems, and regulatory requirements.
- Partner with Operations, Quality, Supply Chain, Digital/Automation, and Capital Project Delivery on assets, technical risks, and operational readiness.
- Build the technical organization, manage contractors and service providers, oversee budgets, and drive continuous improvement.
Requirements
- Doctorate degree and 4 years of engineering experience, or master’s degree and 8 years, or bachelor’s degree and 10 years.
- At least 4 years of direct people management or leadership experience.
- Progressive experience in engineering, maintenance, automation, instrumentation, utilities, reliability, or asset management in pharmaceutical, biotechnology, or similarly regulated manufacturing.
- Experience leading multifunctional technical teams, contractors, and service providers in GMP manufacturing operations.
- Experience with maintenance, calibration, reliability, asset lifecycle, and spare-parts programs in a CMMS environment such as Maximo.
- Strong experience with regulatory inspections, quality events, root-cause investigations, CAPA, capital projects, and operating and capital budgets.
Culture & Benefits
- Health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Discretionary annual bonus and stock-based long-term incentives.
- Paid time off plans and biannual company-wide shutdowns.
- Flexible work models, including remote arrangements where applicable.
- Career development and work-life balance support.
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