Validation Engineer (m/w/d)*
- Entreprise
- Neocleus AG
- Lieu
- St. Gallen
- Date
- 15.06.2025
- Référence
- 123684
Join an Industry Leader Committed to Human Health
SCHOTT Pharma is dedicated to creating science-based solutions that ensure the safety and usability of medications worldwide. Our extensive portfolio includes drug containment and delivery solutions for injectable drugs, featuring prefillable glass and polymer syringes, cartridges, vials, and ampoules. With a diverse team of around 4,700 professionals from over 65 nations, we strive to enhance global healthcare every day.
Your Role in Driving Innovation
As a key contributor within our R&D and Global Engineering division, you will play a vital role in our operations located in St. Gallen, Switzerland. Your responsibilities will include:
- Developing qualification and validation strategies for local and international projects while providing consultation across the organization.
- Planning and executing qualification and validation activities, overseeing project management and coordination within global development and CAPEX projects.
- Conducting and moderating risk analysis, such as GMP-RA and FMEA, aligned with industry specifications and standards.
- Creating, reviewing, and updating key documentation related to qualification and validation.
- Actively participating in the continuous development of qualification and validation to support the ongoing growth of SCHOTT Pharma.
Your Qualifications
- A university degree in engineering, computer science, life sciences, or a related field, complemented by advanced training.
- Over three years of practical experience in qualification and/or validation within a regulated environment, preferably in the pharmaceutical industry.
- In-depth knowledge of GMP, data integrity, GAMP, 21 CFR Part 11, EU-GMP Annex 11, and documentation best practices.
- Strong technical understanding and analytical skills; experience in technical writing is an advantage.
- Intercultural openness, excellent communication skills, and an entrepreneurial, structured working approach.
Why Choose SCHOTT Pharma?
- Opportunities for international assignments.
- Flexible working hours to support work-life balance.
- On-site canteen facilities.
- Convenient access to public transportation.
At SCHOTT Pharma, we connect people with roles that not only match their expertise but also resonate on a personal level. Join us in making a difference in global healthcare.