Aseptic Process Expert – GMP & Validation Lead

Lonza Group Ltd.; Stein (AR); Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile career

Inclusive workplace

Compensation programs

Competitive salary

Lifestyle benefits

Zusammenfassung

Lonza Group Ltd. in Stein, Switzerland, is seeking a proactive, experienced professional to lead aseptic compounding processes within a fully site-based role. You will support operators, drive deviations and investigations, and execute validation activities to maintain top-quality products.

Ideal candidates hold a Life Sciences degree with GMP experience, fluent English and conversational German (B1), and are ready to thrive in a fast-paced environment with changing priorities.

Qualifikationen

• Degree in Life Sciences with hands-on aseptic/sterile manufacturing experience.
• Proven GMP-regulated manufacturing experience.
• Experience in qualification and validation activities.
• Fluent English and conversational German (B1).

Aufgaben

• Lead and continuously improve aseptic compounding processes, leveraging GMP manufacturing experience to ensure safe, compliant, and efficient operations.
• Provide hands-on technical support to operators, troubleshoot process issues, and drive deviations, investigations, and corrective actions to maintain product quality and compliance.
• Execute and support validation and qualification activities, including the preparation, review, and maintenance of all relevant GMP documentation.
• Maintain equipment and processes in an inspection-ready state, support internal and external audits, and contribute expertise in sterile manufacturing environments.
• Collaborate within a proactive, reliable, and accountable team, bringing a BSc/MSc in a scientific discipline, fluent English and conversational German (B1); experience with GMP washers, sterilization processes, thawing, and compounding is an advantage.

Kenntnisse

GMP manufacturing

Aseptic compounding

Hands-on operator support

Deviations & investigations

Documentation

Team collaboration

Fluent English

German (B1)

Ausbildung

BSc/MSc Life Sciences

Tools

GMP washers

Autoclaves

Jobbeschreibung

Lonza Group Ltd. in Stein, Switzerland, is seeking a proactive, experienced professional to lead aseptic compounding processes within a fully site-based role. You will support operators, drive deviations and investigations, and execute validation activities to maintain top-quality products.

Ideal candidates hold a Life Sciences degree with GMP experience, fluent English and conversational German (B1), and are ready to thrive in a fast-paced environment with changing priorities.