Validation Specialist

About SCHOTT Pharma

We design solutions grounded in science to ensure that medications are safe and easy to use for people worldwide – because human health matters. Our portfolio comprises drug containment and delivery solutions for injectable drugs ranging from prefillable glass and polymer syringes, to cartridges, vials, and ampoules.

Become part of our R&D and Global Engineering division at SCHOTT Pharma in St. Gallen, Switzerland. This role will involve travelling to global production sites, approximately 10% of the time.

Your Responsibilities

• You will develop the qualification and validation strategy for local and global projects, consulting 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 according to specifications and standards.
• You will create, review, and update qualification & validation documents.
• You will actively contribute to the continuous development of qualification and validation, supporting the growth of SCHOTT Pharma.

Your Qualifications

• University degree in engineering, computer science, life sciences, or comparable education with advanced training.
• Practical work experience in qualification and/or validation in a regulated environment, preferably in the pharmaceutical industry.
• Solid knowledge of GMP, data integrity, GAMP, 21 CFR Part 11, EU-GMP Annex 11, and good documentation practice.
• Good technical understanding and analytical skills; experience in technical writing is a plus.
• Intercultural openness, good communication skills, and an entrepreneurial and structured way of working.

Your Benefits

At SCHOTT, you can expect a unique corporate culture emphasizing equity, diversity, and inclusion. Motivated and committed employees are the key to our company's success.