Validation Engineer / Validation Engineeress

Neocleus AG - June 19, 2025

Join Our Team as a (Senior) Validation Engineer

SCHOTT Pharma is committed to designing solutions grounded in science to ensure that medications are safe and easy to use for people worldwide. Our portfolio includes drug containment and delivery solutions for injectable drugs, encompassing prefillable glass and polymer syringes, cartridges, vials, and ampoules. Every day, a dedicated team of approximately 4,700 individuals from over 65 nations works at SCHOTT Pharma to contribute to global healthcare.

We invite you to apply online using the form below for the (Senior) Validation Engineer position within our R&D and Global Engineering division at SCHOTT Pharma. This role is based at our site in St. Gallen, Switzerland, with project-specific travel to global production sites, estimated at around 10%.

Your Responsibilities

  • Develop the qualification and validation strategy for local and global projects and provide consultancy across the organization on qualification and validation matters.
  • Accountable for the planning and execution of qualification & validation activities, including project management and coordination within global development and CAPEX projects worldwide.
  • Conduct and facilitate risk analysis (e.g., GMP-RA, FMEA) according to specifications and standards.
  • Create, review, and update qualification & validation documents (e.g., plan, test plan, protocol, report).
  • Actively enhance the continuous development of qualification and validation, supporting the growth of SCHOTT Pharma.

Your Qualifications

  • University degree in engineering, computer science, life sciences, or a comparable field, complemented by advanced training.
  • Over 3 years of practical experience in qualification and/or validation within a regulated environment (pharmaceutical industry preferred) with an appropriate mindset.
  • In-depth knowledge of GMP (Good Manufacturing Practice), data integrity, GAMP, 21 CFR Part 11, EU GMP Annex 11, and good documentation practices.
  • Strong technical understanding and analytical skills; experience in technical writing is a plus.
  • Intercultural openness, good communication skills, and an entrepreneurial, structured approach to work.

Your Benefits

  • International assignments
  • Flexible working hours
  • Canteen
  • Access to public transportation

Only applications matching the job profile will be considered.

Location : St. Gallen
Country : Switzerland

Application Form

Please enter your information in the following form and attach your resume (CV)

Only pdf, Word, or OpenOffice file. Maximum file size: 3 MB.