Qualification/Validation Engineer CSV 100% (m/f/d)

What is my role?

Our client is looking for you for the following tasks:

• Planning, coordination and execution of CSV validations

• Execution of qualifications/validations of processes, systems, equipment, media, rooms in close cooperation with internal departments

• Support of the QV group in all GMP matters

• Participation in the validation strategy and further development of the master validation plan

• Creation, editing, review and maintenance of all documents related to calibration, qualification/validation (e.g. plans/reports, SOPs) in compliance with GMP requirements

• Contribution to the improvement of processes and workflows within the QV team

• Ensuring timely processing of activities

• Participation in inspections and audits as well as their preparation and follow-up in close coordination with quality assurance and other involved parties

What do I need to be successful?

You bring the following:

• Degree in a technical or scientific field from a university or university of applied sciences, or technical training with further education in the GMP area

• Experience in the validation of computerised systems as well as handling software and Excel applications

• Professional experience in the GMP area of CSV validation, qualification/validation of systems and processes in the pharmaceutical industry, biotechnology or medical technology, knowledge of the requirements from Annex 11 and Annex 15 of the EU GMP guidelines

• Fluent German and good English skills, both written and spoken

• Structured, independent working style and analytical thinking, hands-on mentality, confident appearance with internal and external parties

What are my benefits?

You can look forward to:

• A responsible and varied role in an exciting environment within a family business shaped by tradition and innovation

• A motivated team and close interdisciplinary collaboration

• Flexible working hours and an above-average pension scheme

What distinguishes the company?

Our client is a family business shaped by tradition and innovation in the pharmaceutical industry, offering you an exciting working environment with interdisciplinary collaboration.

Languages
German: C2 - Native level

Workplace
Uznach

Vacancy number
VA-GGR-8PJ