Sterilisation & Validation Expert: Quality & Compliance Lead

Ophtapharm AG; Hettlingen; On-site; CHF 110,000 - 170,000; Full time

Benefits offered by this job

Pension scheme

Flexible working conditions

Free parking

Job summary

Ophtapharm AG in Hettlingen (ZH) is seeking a Sterilisation & Validation Expert to lead external sterilisation activities and maintain validation documentation. You will work closely with internal stakeholders to ensure the highest standards of product quality, compliance and patient safety in sterile ophthalmic medicines.

You will collaborate with external providers and internal teams to shape validation strategies, support SIP and bulk product validation, and ensure robust processes in a

Qualifications

• Strong knowledge of sterilisation technologies such as ETO and Steam.
• Experience with sterilisation validation in a regulated environment.
• Background in aseptic pharmaceutical manufacturing.
• Confident communication in English and cross-functional collaboration.

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.

Skills

Sterilisation technologies

ETO

Steam

Communication (English)

Job description

Ophtapharm AG in Hettlingen (ZH) is seeking a Sterilisation & Validation Expert to lead external sterilisation activities and maintain validation documentation. You will work closely with internal stakeholders to ensure the highest standards of product quality, compliance and patient safety in sterile ophthalmic medicines.

You will collaborate with external providers and internal teams to shape validation strategies, support SIP and bulk product validation, and ensure robust processes in a