Validation Specialist
vor 1 Monat
About SCHOTT Pharma
We design innovative solutions to ensure the safety and usability of medications worldwide. Our portfolio includes drug containment and delivery solutions for injectable drugs, from prefillable glass and polymer syringes to cartridges, vials, and ampoules. Our team of around 4,700 people from over 65 nations works together to contribute to global healthcare.
Join our R&D and Global Engineering division
We are seeking a (Senior) Validation Engineer* to join our team at SCHOTT Pharma in St. Gallen, Switzerland. This role will involve travelling to global production sites for project-specific tasks, approximately 10% of the time.
Your Key Responsibilities
- You will develop the qualification and validation strategy for local and global projects, consulting with the organization on qualification and validation matters.
- You will be accountable for planning and executing qualification & validation activities, including project management and coordination, within global development and CAPEX-projects worldwide.
- You will perform and moderate risk analysis (GMP-RA, FMEA) according to specifications and standards.
- You will create, review, and update qualification & validation documents (plan, test plan, protocol, report).
- You will contribute to the continuous development of qualification and validation, supporting the growth of SCHOTT Pharma.
Your Qualifications
- You hold a university degree in engineering, computer science, life sciences, or a comparable education with advanced training.
- You have practical work experience (> 3 years) in qualification and/or validation in a regulated environment, preferably in the pharmaceutical industry, with the appropriate mindset.
- You possess solid knowledge of GMP (Good Manufacturing Practice), data integrity, GAMP, 21 CFR Part 11, EU-GMP Annex 11, and good documentation practice.
- You have good technical understanding and analytical skills, with experience in technical writing being a plus.
- You demonstrate intercultural openness, good communication skills, and an entrepreneurial and structured way of working.
Your Benefits
At SCHOTT, you can expect a unique corporate culture that emphasizes equity, diversity, and inclusion. We know that motivated and committed employees are the key to our company's success.
Get in touch with us
You can expect interesting tasks and challenging projects, as well as motivated and friendly teams in fields that shape our future. If you want to be successful with us, then
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