Sterilisation & Validation Expert

Ophtapharm, a Sentiss Company; Zürich; Vor Ort; CHF 110.000 - 160.000; Vollzeit

Benefits dieser Stelle

Flexible working conditions

Pension scheme

Free parking

Zusammenfassung

Ophtapharm AG, part of Sentiss, seeks a Qualification & Validation expert to own sterilisation processes and validation activities. You will work with internal stakeholders and external partners to uphold quality and patient safety.

In this role you will lead external sterilisation activities, prepare validation documentation, and support SIP and bulk product validation. You will influence strategy and ensure regulatory compliance in a dynamic environment.

Qualifikationen

• Knowledge of sterilisation technologies (Gamma, ETO, Steam).
• Experience with sterilisation validation in regulated environments.
• Background in aseptic pharmaceutical manufacturing.

Aufgaben

• Lead external sterilisation activities for active ingredients, excipients, and packaging materials.
• Prepare, review, and maintain sterilisation validation documentation.
• Support SIP and bulk product validation activities.
• Manage filter validation programs and ensure regulatory compliance.
• Build strong partnerships with external sterilisation service providers.

Kenntnisse

Sterilisation tech

Sterilisation validation

Aseptic manufacturing

German language

English language

Jobbeschreibung

At Ophtapharm AG, we manufacture sterile ophthalmic medicines that help patients around the world protect and improve their vision. As an FDA and EU-GMP certified pharmaceutical company, quality is at the heart of everything we do.

As part of our Qualification & Validation Team within the Quality Department, you will be the go-to expert for sterilisation processes and validation activities. Working closely with internal stakeholders and external partners, you will help ensure the highest standards of product quality, compliance, and patient safety.

Your Role

• Lead external sterilisation activities for active ingredients, excipients, and packaging materials.
• Prepare, review, and maintain sterilisation validation documentation.
• Support SIP and bulk product validation activities.
• Manage filter validation programs and ensure regulatory compliance.
• Build strong partnerships with external sterilisation service providers.

Your Profile

• Strong knowledge of sterilisation technologies such as Gamma, ETO, and Steam.
• Experience with sterilisation validation in a regulated environment.
• Background in aseptic pharmaceutical manufacturing.
• Confident communication skills in German and English.
• Structured and solution-oriented mindset with a strong focus on quality and compliance.

What you can expect

• A specialist role where your expertise directly contributes to product quality, compliance, and patient safety.
• The opportunity to shape and further develop validation and sterilisation processes.
• A key expert role with significant influence on validation strategy and sterile manufacturing operations.
• A dynamic environment with short decision-making paths and room for new ideas.
• Flexible working conditions, an attractive pension scheme, and convenient access by public transport or free parking.

For recruitment agencies:

Thank you for your interest. We are not engaging external support for this role.