Administrator Qualification / Validation; Sterilization Validation (Temporary Employment)
Ophtapharm AG
Hettlingen CH
Key information
- Publication date:02 October 2025
- Workload:100%
- Contract type:Permanent position
- Place of work:Hettlingen CH
Job summary
Ophtapharm AG is an FDA/EU-GMP certified producer of ophthalmic products. Join a dynamic team in a supportive work environment with great development opportunities.
Tasks
- Conduct project planning and execution for equipment qualifications.
- Perform cleanroom qualifications and flow visualizations per ISO 14644.
- Support qualification and validation projects and process optimizations.
Skills
- Technical or scientific education with 5+ years in equipment qualification.
- Strong knowledge of relevant regulatory guidelines and GMP experience.
- Excellent communication skills in German and English.
Is this helpful?
Ophtapharm AG is an FDA/EU-GMP certified manufacturer in the pharmaceutical sector (ophthalmics). At our production site in Hettlingen near Winterthur, high-quality products such as eye drops, ointments, and gels are aseptically produced, filled, and packaged for international markets.
Administrator Qualification / Validation; Sterilization Validation (Temporary Employment)
To strengthen our team in Hettlingen, we are looking for a
Your tasks
- Planning and execution of equipment qualifications (including tanks, autoclaves, sterilizers) with a focus on the qualification of sterilization processes including the necessary documentation
- Cleanroom qualifications and flow visualizations (smoke studies) according to ISO 14644
- Support in qualification and validation projects
- Development of problem solutions
- Participation in process optimization projects
- Creation and training of required guidelines and SOPs
- Representation of the department during regulatory inspections and customer audits
Your profile
- Technical and scientific education (pharmaceutical/process/food technology)
- At least 5 years of experience in equipment qualification
- Several years of GMP experience (EU, FDA)
- Confident knowledge of relevant regulatory requirements
- Knowledge of pharmaceutical, aseptic production technology and processes
- Very good German and English skills, both spoken and written
- Good communication skills as a contact point for many departments
Your benefits
- Dynamic environment with development opportunities
- Possibility of partial home office (depending on function)
- In our uncomplicated company culture, we clearly prefer the "du" (informal you) over the "Sie" (formal you)
- Free parking and public transport connections within walking distance
Do you have questions?
HR Hettlingen, Human Resources, will be happy to answer them. Tel: +41 52 304 12 36.
HR Hettlingen, Human Resources, will be happy to answer them. Tel: +41 52 304 12 36.
