Manufacturing Execution System (mes) Project Lead

Johnson & Johnson Johnson & Johnson · Pharma · Beerse, Antwerp, Belgium

Lead the implementation of a Manufacturing Execution System (MES) for the Beerse site, involving the conversion of batch information to a digital system with workflow management, integrated with various key systems. This role requires overall execution and program delivery within scope, schedule, budget, and regulatory requirements.

What you'd actually do

  1. Own overall execution and program delivery within scope, schedule, budget and quality/regulatory requirements.
  2. Manage the deployment to ensure timely/high quality deliverables
  3. Own project planning, resourcing, monitoring and adherence to plan
  4. Maintain and control project budget
  5. Partner with the Business Lead to ensure that the end-state, integrated, solution meets business needs across all impacted functions (end-to-end)

Skills

Required

  • Bachelor's degree in science-based discipline
  • 10 years of experience in operations and project management in Pharmaceuticals
  • Knowledge of applicable regulations and regulatory processes
  • Knowledge of Automation and IT related systems in regulated environment
  • Proficient in English & Dutch

Nice to have

  • Bachelor's or higher degree in Life Sciences discipline, Pharmacy or Chemical Engineering
  • Demonstrated knowledge of Good Manufacturing Practice (GMP) regulations
  • Proven understanding of GAMP and SDLC requirements
  • Knowledge in Quality and/or Regulatory Compliance field, preferably in Pharmaceuticals
  • Ability to work across organizational boundaries in a global matrix organization
  • Strong decision making and problem solving competencies
  • Strong conceptual leadership skills

What the JD emphasized

  • Knowledge of the applicable regulations and regulatory processes.
  • Knowledge of Automation and IT related systems in regulated environment