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Group Head MSAT Equipment Qualification (80-100%)

lonza · Stein

New
Senior 🇬🇧 English
Equipment qualification Process validation GMP Single-use systems Aseptic manufacturing

Job description

About the role

Lonza is hiring a Group Head for MSAT Equipment Qualification and Process Platforms in Stein, Switzerland, a fully site-based role working 80-100% of the time. The position leads a high-performing team responsible for the qualification, governance and continuous development of critical sterile manufacturing processes and technologies, defining lifecycle strategies that ensure compliance, reliability and manufacturing robustness. Relocation assistance is available for eligible candidates and their families.

Key responsibilities

  • Lead the Equipment Qualification and Process Platforms function, accountable for people, resources, capabilities, priorities, performance and delivery.
  • Build and develop MSAT expertise through resource planning, coaching, talent development and succession planning.
  • Set the strategic direction for equipment qualification and process platforms, turning site and business priorities into functional objectives and capability plans.
  • Ensure capability and governance for critical sterile technologies such as isolators, H2O2/VHP decontamination, thermal sterilization, filling and closing systems and freeze-dryers.
  • Provide functional leadership for Drug Product Process Platform ownership, covering thawing, compounding, mixing, sterilizing filtration, filling, stoppering and crimping.
  • Maintain Single-Use Systems (SUS) capabilities, expertise and technical governance.
  • Establish and maintain the MSAT technical governance framework and standards aligned with GMP and regulatory expectations.
  • Represent the function as senior technical authority in cross-functional governance, customer interactions, audits, regulatory inspections and Health Authority engagements.
  • Drive continuous improvement, standardization, knowledge management and adoption of new technologies.
  • Partner with PHAD, MSAT Tech Transfer, Engineering, Operations and global functions such as Global Operations, Material Excellence and the DS network.

Required profile

  • MSc or PhD in Pharmaceutical Sciences, Pharmaceutical Engineering, Chemistry, Bioengineering, Biochemistry or a related discipline.
  • Solid experience in sterile drug product (fill & finish) manufacturing environments is a must.
  • Demonstrated expertise in equipment qualification, lifecycle management, process validation and aseptic manufacturing technologies.
  • Strong knowledge of GMP and regulatory requirements, with audit and inspection support experience.
  • Fluent English; German is an advantage. Previous people leadership experience is a plus.

Required skills

  • Equipment qualification and process validation
  • Aseptic manufacturing and single-use systems
  • GMP and regulatory compliance
  • Stakeholder management and technical leadership

What we offer

  • An agile career and dynamic working culture in an inclusive, ethical workplace.
  • Compensation programs recognizing high performance and benefits depending on role and location.
  • Relocation assistance for eligible candidates and their families.

Questions fréquentes

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Source : ats:workday

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Published 2 hours ago

Expires 1 month from now

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lonza

Stein