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F.F. Hoffmann-La Roche AG

Senior Technical Sub-Project Manager Packaging & Assembly(m/w/x)

Kaiseraugst
Full-timeOn-siteSenior

Technical leadership for automated assembly and packaging lines at global healthcare company. Management of complex, multidisciplinary projects required. Shift work, 4-day work week.

Requirements

  • Highly disciplined technical leadership
  • Strong sense of accountability
  • Management of complex, multidisciplinary projects
  • Exceptional problem-solving skills
  • Analytical mindset for technical issue resolution
  • Effective communication for stakeholder alignment
  • Effective leadership of external partners
  • Bachelor’s Degree in Mechanical Engineering, Mechatronics, or related technical discipline
  • Expertise in collaborating with equipment manufacturers
  • Expertise in executing FAT/SAT
  • Expertise in managing commissioning and qualification activities
  • Profound knowledge of regulatory requirements (FDA, EMA, GMP)
  • Profound knowledge of standards for combination products (ISO 13485, EU MDR)
  • Ability to execute complex scopes in investment projects
  • Willingness to travel (50% or more)
  • Readiness for international assignments of 1 to 3 years

Tasks

  • Provide technical leadership for automated manufacturing systems
  • Lead planning, design, and procurement of assembly and packaging lines
  • Manage project lifecycle from concept to commercial ramp-up
  • Oversee sub-project budgets, schedules, and resource planning
  • Align with stakeholders and project management team
  • Act as primary technical and commercial interface for suppliers
  • Drive engineering for state-of-the-art assembly systems
  • Lead packaging system projects for traceability and data integrity
  • Define and execute qualification strategies
  • Ensure compliance with ISO 13485, EU MDR, EU GMP, FDA CFR 21, and GAMP 5
  • Serve as technical SME during regulatory inspections and audits

Work Experience

  • 8 - 12 years

Education

  • Bachelor's degree

Languages

  • EnglishBusiness Fluent
  • GermanBusiness Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of F. Hoffmann-La Roche AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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