Sterilisation & Validation Expert

About the role

Join Ophtapharm AG’s Qualification & Validation Team to become the go‑to expert for sterilisation processes and validation activities, ensuring the highest standards of product quality, compliance, and patient safety.

Key responsibilities

• 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.

Required 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, solution‑oriented mindset with a strong focus on quality and compliance.

Required skills

• Gamma sterilisation
• Ethylene oxide (ETO) sterilisation
• Steam sterilisation
• Validation documentation
• Filter validation

What we offer

• Specialist role directly contributing to product quality, compliance, and patient safety.
• Opportunity to shape and further develop validation and sterilisation processes.
• Key expert position with significant influence on validation strategy and sterile manufacturing operations.
• Dynamic environment with short decision‑making paths and room for new ideas.
• Flexible working conditions, attractive pension scheme, and convenient access by public transport or free parking.