MSAT Expert- Contamination Control 80-100%

Lonza; Stein; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile career culture

Inclusive workplace

Competitive compensation

Zusammenfassung

Lonza in Stein, AG, is seeking a senior specialist to own the Contamination Control Strategy for a state-of-the-art sterile manufacturing facility. You will lead APS/Media Fills, EMPQ, Smoke Studies, Cleaning Validation and risk assessments to ensure inspection readiness and regulatory compliance while supporting lifecycle programs across the site.

This fully site-based role emphasizes real-time collaboration, strategic technical leadership, and driving continuous improvement in sterility

Qualifikationen

• Experience in aseptic Drug Product manufacturing, including Fill & Finish.
• Expertise in Cleaning Validation or Contamination Control Strategy (CCS) within sterile manufacturing.
• Degree in Engineering, Life Sciences, or Pharmaceutical Sciences, with fluent English.

Aufgaben

• Act as SME for Sterility Assurance, Contamination Control and Cleaning Validation.
• Lead CCS implementation and risk assessments across site.
• Support lifecycle strategy and validation activities (APS/Media Fills, EMPQ, Smoke Studies).
• Develop and sustain Cleaning Validation protocols and strategies.
• Drive investigations, deviations, CAPAs and continuous improvement with cross-functional partners.

Kenntnisse

Sterility Assurance

Contamination Control

Cleaning Validation

APS/Media Fills

Risk Assessments

Cross-functional Collaboration

Regulatory Inspections

Ausbildung

Engineering / Life Sciences / Pharmaceutical Sciences degree

Jobbeschreibung

Switzerland, Stein

The actual location of this job is in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

In this role, you will shape and drive the Contamination Control Strategy (CCS) for a state-of-the-art sterile manufacturing facility, leading key initiatives such as APS/Media Fills, EMPQ, Smoke Studies, Cleaning Validation and associated risk assessments to ensure inspection readiness and operational excellence. Join a highly ambitious greenfield project that is a cornerstone of Lonza’s Drug Product expansion, where you will provide strategic technical expertise, supporting the implementation, maintenance and continuous improvement of contamination control, sterility assurance and cleaning validation programs to ensure regulatory compliance and robust manufacturing performance throughout the product lifecycle and help establish one of Switzerland’s most innovative sterile manufacturing sites. Check out Your Career in Drug Product Services at Lonza!

This is a fully site-based role. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What You Will Get

• An agile career and a dynamic work culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.

In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits.

The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits

Our local benefits: 3cf206339e0e4e41a77e8c806138c2b5

What You Will Do

• Act as Subject Matter Expert for Sterility Assurance, Contamination Control and Cleaning Validation, providing strategic technical leadership to support compliant, efficient and inspection-ready sterile manufacturing operations.
• Support the implementation, maintenance and continuous improvement of the facility-wide Contamination Control Strategy (CCS), driving risk assessments, cross-contamination prevention measures and robust contamination control programs across the site.
• Support the lifecycle strategy and execution of key sterility assurance programs, including Aseptic Process Simulations (APS/Media Fills), Environmental Monitoring Performance Qualification (EM PQ), Smoke Studies, EMPQ and associated validation activities.
• Develop, optimise and sustain Cleaning Validation protocols, strategies and lifecycle programs, closing compliance gaps, strengthening process robustness and ensuring effective validation of equipment, facilities and manufacturing processes.
• Drive complex investigations, deviations, CAPAs and continuous improvement initiatives while partnering across functions to support facility start-up, project delivery, regulatory inspections and the successful growth of a landmark greenfield sterile manufacturing facility.

What We Are Looking For

• Hands-on experience in aseptic Drug Product manufacturing, including Fill & Finish operations for vials and/or syringes, with a strong understanding of sterile processing principles.
• Proven expertise in either Cleaning Validation or Contamination Control Strategy (CCS) within sterile drug product manufacturing.
• Solid understanding of cleanroom classifications, material flows, HVAC concepts and contamination control principles, combined with the ability to perform and document risk-based assessments.
• Degree in Engineering, Life Sciences, Pharmaceutical Sciences or a related discipline, with fluent English communication skills and the ability to collaborate effectively across diverse technical and operational stakeholders.
• Agile, proactive and solutions-oriented mindset, with the ability to thrive in a fast-paced, dynamic environment and drive alignment across multiple functions; experience supporting regulatory inspections and health authority interactions (e.g. FDA, Swissmedic) is a plus.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Reference: R79594