Senior MSAT Equipment Qualification Lead

Lonza; Schweiz; On-site; Vertraulich; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Competitive compensation programs

Variety of benefits depending on role

Job summary

Lonza is seeking a leader to head the Equipment Qualification & Process Platforms function at our Stein, AG site, Switzerland. You will manage people, resources and delivery across MSAT, shaping qualification strategies for sterile drug manufacturing technologies.

With a MSc/PhD in a relevant field, you will drive process platforms, SUS governance, and lifecycle strategies, collaborating across PHAD, MSAT Tech Transfer, Engineering and Operations to ensure top quality and regulatory compliance.

Qualifications

• 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 experience supporting regulatory inspections.

Responsibilities

• Lead the Equipment Qualification & Process Platforms function with accountability 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 Platform activities, translating priorities into objectives and capability plans.
• Ensure capability and governance for sterile-manufacturing technologies, including isolator tech, decontamination, sterilization, filling and closing systems and freeze-dryers.
• Provide governance for Drug Product Process Platform ownership, ensuring lifecycle strategies for thawing, compounding, filtration, filling, stoppering and related tech.
• Ensure capabilities and governance for Single‑Use Systems are established to support site and business needs.
• Establish MSAT governance framework and standards for Equipment Qualification and Process Platforms, aligning with GMP and Lonza standards.

Skills

Sterile manufacturing

Equipment qualification

Lifecycle management

Process validation

Aseptic tech

GMP knowledge

Education

MSc or PhD in Pharmaceutical Sciences/Engineering/Chemistry/Biochem

Job description

Lonza is seeking a leader to head the Equipment Qualification & Process Platforms function at our Stein, AG site, Switzerland. You will manage people, resources and delivery across MSAT, shaping qualification strategies for sterile drug manufacturing technologies.

With a MSc/PhD in a relevant field, you will drive process platforms, SUS governance, and lifecycle strategies, collaborating across PHAD, MSAT Tech Transfer, Engineering and Operations to ensure top quality and regulatory compliance.