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Miltenyi Biotec
8d ago

Process Design Expert - Cell & Gene Therapy(m/w/x)

Bergisch Gladbach
Full-timeWith Home OfficeExperienced

Description

You will shape the future of cell and gene therapy by designing scalable supply chain processes and digital tools, ensuring seamless, compliant operations from clinical trials to commercial delivery.

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Requirements

  • •University degree in engineering, life sciences, supply chain/operations, or related field
  • •Experience in process design and GxP documentation within regulated environments
  • •Management consulting experience as a plus
  • •Strong operational excellence skill set
  • •Ability to translate complex requirements into auditable workflows
  • •Hands-on experience with commercial or clinical supply chain processes
  • •Effective communication and stakeholder management skills
  • •Reliability and detail-orientation
  • •Proactive and solution-oriented mindset

Education

Bachelor's degree

Work Experience

approx. 1 - 4 years

Tasks

  • •Design and harmonize core supply chain processes
  • •Optimize digital tools and documentation
  • •Map and reengineer global workflows
  • •Draft SOPs and risk assessments
  • •Translate business requirements into technical specifications
  • •Support equipment and process qualification
  • •Oversee process alignment with Quality Assurance
  • •Manage audits, trainings, and compliance activities
  • •Enhance digital tools for better usability
  • •Drive cross-functional alignment with manufacturing and clinical teams

Tools & Technologies

GxP documentationSOPsWork instructionsRisk assessmentsProcess mappingKPI definitionGMP quality interfaces

Languages

English – Business Fluent

Benefits

Flexible Working

  • •Free and self-determined time management
  • •Mobile working

More Vacation Days

  • •30 days of vacation

Corporate Discounts

  • •Discounted ticket to Germany

Company Bike

  • •(e)-bike leasing

Additional Allowances

  • •Capital-forming benefits

Retirement Plans

  • •Company pension plan

Other Benefits

  • •Disability insurance

Free or Subsidized Food

  • •Canteen
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