8 дней назад
Site Automation Lead (Pharma)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Site Automation Lead (Pharma): Leading automation and execution systems for a regulated biopharmaceutical manufacturing site with an accent on ISA-95 Level 1–3 systems, compliance, reliability, and digital manufacturing. Focus on developing the automation organization, delivering validated automation projects, managing lifecycle documentation, and ensuring 24/7 system performance.
Location: Leiden, South Holland, Netherlands; manufacturing site
Company
Johnson & Johnson MedTech develops healthcare and medical technology solutions across Innovative Medicine and MedTech.
What you will do
- Lead and develop the site automation organization, including individual contributors, supervisors, and managers.
- Define and execute the site automation and execution systems strategy, ensuring standardization and architectural alignment.
- Lead automation and data-driven projects with compliant, safe, on-time, and within-budget delivery.
- Oversee execution systems across design, validation, integration, master data, recipes, and lifecycle documentation.
- Ensure system reliability, upgrades, continuous improvement, infrastructure coordination, and effective 24/7 support.
- Manage cross-functional stakeholders, vendors, contracts, governance, policies, procedures, and performance KPIs.
Requirements
- BSc in Engineering, Science, or a related technical field with 10+ years of manufacturing experience, or an advanced degree with 8+ years of experience.
- 4+ years of leadership and delivery experience and 4+ years in pharmaceutical or GMP-regulated manufacturing automation or IT.
- Strong knowledge of cGMP, FDA-regulated environments, validation practices including FAT, SAT, and IO/PQ, and GAMP principles.
- Deep expertise in ISA-95 Level 1–3 systems, including DeltaV, PLCs, MES PAS-X, OSI PI, and infrastructure, plus understanding of Level 4 system integration.
- Experience applying ISA-95 and ISA-88, managing projects and finances, translating business needs into technical solutions, and leading change across a matrix organization.
- Fluent English required; Dutch is advantageous.
Culture & Benefits
- Inclusive work environment focused on individual dignity, diversity, and employee development.
- Leadership role within the Global Engineering & Technology organization and the Leiden leadership team.
- Work in a regulated manufacturing environment focused on compliance, innovation, and operational excellence.
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