Sterilisation & Validation Expert

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.

• 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.

• 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.

• 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.

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