Sterilisation & Validation Expert (80-100%)

Ophtapharm AG; Hettlingen; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Pension scheme

Free parking

Public transport access

Zusammenfassung

Ophtapharm AG is seeking a Sterilisation & Validation Expert to lead external sterilisation activities and validation tasks within the Qualification & Validation Team. You will ensure the highest quality, compliance, and patient safety across ophthalmic medicines.

Join a dynamic environment with significant influence on validation strategy and sterile manufacturing operations. Flexible working conditions and a strong pension scheme complement the role, with easy access by public transport and

Qualifikationen

• Strong knowledge of sterilisation technologies (Gamma, ETO, Steam) and validation methods.
• Experience in regulated pharmaceutical environments with GMP/quality focus.
• Confident communication in German and English.
• Structured, quality- and compliance-driven mindset.

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 technologies

Quality & compliance

German & English communication

Ausbildung

Aseptic pharmaceutical manufacturing background

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.

Sterilisation & Validation Expert (80-100%)

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. Join us in ensuring that high‑quality ophthalmic medicines reach patients around the world safely and reliably.

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.

Do you have any questions?

Our HR team is happy to assist you. Tel: [phone].