Ems Associate

Johnson & Johnson Johnson & Johnson · Pharma · Gent, East Flanders, Belgium

The EMS Associate, CAR-T Belgium role supports the production of CAR-T cell therapies in a cGMP-controlled cleanroom environment. Responsibilities include microbiological and aseptic oversight, contamination control, environmental monitoring program management, and supporting investigations. The role collaborates with Process Development, Quality, and Operations teams to ensure compliance with cGMP requirements and deliver life-changing therapies.

What you'd actually do

  1. Collaborate with Process Development, Quality, and Operations teams to maintain effective contamination control in manufacturing environments aligned with cGMP requirements
  2. Lead environmental monitoring (EM) performance qualification for CAR-T facilities and utilities
  3. Design, implement, and manage a comprehensive end-to-end environmental monitoring program
  4. Author and maintain EM-related documentation, including protocols, reports, SOPs, and work instructions
  5. Establish and manage environmental monitoring trending systems to track and analyze data

Skills

Required

  • Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline
  • Experience in the pharmaceutical or biotechnology industry, preferably in microbiology, cell therapy, or manufacturing environments
  • Strong knowledge of aseptic processing in ISO 5 cleanrooms and biosafety cabinets
  • Solid understanding of cGMP, FDA/EU regulations, and Good Tissue Practices for cell-based products
  • Proven experience in establishing and managing environmental monitoring programs
  • Strong organizational, communication, and documentation skills, with the ability to present findings clearly
  • Team-oriented mindset with problem-solving skills, adaptability, and the ability to work within structured procedures while navigating ambiguity

Nice to have

  • Business Alignment
  • Business Behavior
  • Coaching
  • Compliance Management
  • Continuous Improvement
  • Data Analysis
  • Detail-Oriented
  • Goal Attainment
  • Human-Centered Design
  • Internal Controls
  • Issue Escalation
  • Problem Solving
  • Process Oriented
  • Quality Control (QC)
  • Quality Management Systems (QMS)
  • Quality Standards

What the JD emphasized

  • cGMP requirements
  • aseptic processing
  • contamination control