About SCHOTT Pharma
We design solutions grounded in science to ensure that medications are safe and easy to use for people around the world, 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.
A team of around 4,700 people from over 65 nations works at SCHOTT Pharma to contribute to global healthcare every day.
Become a Senior Validation Engineer* within our R&D and Global Engineering division.
This position will be located at our site in St. Gallen, Switzerland, with occasional travelling to global production sites approximately 10% of the time.
Your Key Responsibilities
* You develop qualification and validation strategies for local and international projects and provide consultation on the subject of qualification and validation across the organization.
* You are accountable for planning and executing qualification & validation activities (including project management and coordination) within global development and CAPEX-projects worldwide.
* You perform and moderate risk analysis (GMP-RA, FMEA) according to specifications and standards.
* You create, review, and update qualification & validation documents (plan, test plan, protocol, report).
* You shape the continuous development of qualification and validation and support the growth of SCHOTT Pharma.
Your Required Qualifications
* You hold a university degree in engineering, computer science, life sciences or comparable education including advanced training.
* You have practical work experience (> 3 years) in qualification and/or validation in a regulated environment (pharmaceutical industry desirable) with an 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; experience in technical writing is a plus.
* You demonstrate intercultural openness, good communication skills, and an entrepreneurial and structured way of working.
Your Benefits
At SCHOTT Pharma, you can expect a unique corporate culture emphasizing equity, diversity, and inclusion.
Motivated and committed employees are essential for the success of our company.
Challenging Projects and Collaborative Teams
You can expect interesting tasks, challenging projects, and motivated and friendly teams in fields that influence our future.