Aseptic Process Expert - GMP & Validation Lead

Lonza Group Ltd.; Stein; On-site; Confidential; Full time

Benefits offered by this job

Competitive salary

Lifestyle benefits

Global benefits overview

Local Stein benefits

Job summary

Lonza Group Ltd. in Stein, Switzerland, is seeking an experienced professional to lead aseptic compounding processes on a fully site-based role.

You will provide hands-on technical support to operators, drive deviations and investigations, and execute validation and qualification activities to ensure GMP-compliant, high-quality manufacturing. Requirements include a BSc/MSc in Life Sciences, fluent English and conversational German (B1), and hands-on GMP experience.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences with hands-on experience in aseptic/sterile manufacturing environments.
• Proven experience in GMP-regulated manufacturing with a strong focus on quality, compliance, and documentation requirements.
• Experience in qualification and validation activities is a strong advantage.
• Fluent English and conversational German (B1 level or above) enabling effective cross-team communication.
• Proactive, reliable team player who thrives in a fast-paced environment with changing priorities.
• Comfortable navigating ambiguity; experience with thawing and compounding operations and knowledge of GMP washers and autoclaves is advantageous.

Responsibilities

• 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 preparation, review, and maintenance of 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 in a fast-paced setting with changing priorities.

Skills

Aseptic manufacturing

GMP compliance

Deviation management

Investigations

Validation & qualification

Technical support

Documentation

Education

Bachelor’s or Master’s degree in Life Sciences

Tools

GMP washers

Autoclaves

Sterilization processes

Qualification activities

Job description

Lonza Group Ltd. in Stein, Switzerland, is seeking an experienced professional to lead aseptic compounding processes on a fully site-based role.

You will provide hands-on technical support to operators, drive deviations and investigations, and execute validation and qualification activities to ensure GMP-compliant, high-quality manufacturing. Requirements include a BSc/MSc in Life Sciences, fluent English and conversational German (B1), and hands-on GMP experience.