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6 дней назад

Digitalization Lead, MES/SAP

Формат работы
onsite
Тип работы
fulltime
Грейд
lead
Английский
c2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Digitalization Lead, MES/SAP (Pharmaceutical Manufacturing): Driving the digital transformation roadmap and implementing, integrating, and optimizing ERP, LIMS, and MES systems at a pharmaceutical manufacturing site with an accent on GMP validation, FDA/EMA compliance, and data integrity. Focus on managing cross-functional implementation projects, coordinating global stakeholders, and delivering compliant manufacturing and supply chain solutions.

Location: Middletown, DE, United States; on-site

Company

hirify.global operates in pharmaceutical and biotechnology manufacturing and provides contract development and manufacturing services.

What you will do

  • Develop the site digitalization roadmap covering ERP, LIMS, MES, and related systems.
  • Lead end-to-end implementation, upgrades, integration, and maintenance of ERP platforms such as SAP or Oracle.
  • Lead manufacturing execution and operations management system initiatives, including MES and WMS.
  • Coordinate IT, Manufacturing, Quality, Supply Chain, global teams, and vendors for project execution.
  • Manage project budgets, timelines, risks, milestones, governance, and leadership reporting.
  • Ensure digital solutions support pharmaceutical manufacturing operations and regulatory requirements.

Requirements

  • Bachelor’s or Master’s degree in Computer Science, IT, or a related field.
  • At least 5 years of digital project management experience in pharmaceutical manufacturing, biotech, or CDMO environments, with strong GMP/GxP knowledge.
  • At least 3 years of hands-on experience implementing large-scale ERP systems such as SAP or Oracle, including manufacturing and supply chain modules.
  • Knowledge of cGMP, 21 CFR Part 11, FDA/EMA data integrity principles, ALCOA+, and computer system validation is required.
  • Experience managing cross-functional teams and vendors, with strong project management capabilities; PMP or PRINCE2 certification is preferred.
  • Native or professional English fluency is required. Mandarin is a plus for coordination with global stakeholders.

Nice to have

  • Experience at multinational pharmaceutical or CDMO manufacturing sites.
  • Knowledge of drug discovery and pharmaceutical process development.
  • PMP or PRINCE2 certification.
  • Mandarin language skills.

Culture & Benefits

  • Cross-functional collaboration across IT, Manufacturing, Quality, and Supply Chain.
  • Coordination with global teams and international stakeholders.
  • Work focused on regulated pharmaceutical manufacturing and digital transformation.
  • Equal opportunity employment.

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