Job Detail

Introduction

ALTEN, the European leader in engineering and technology consulting, provides support for its clients’ development strategies in the fields of innovation, R&D and it systems. Its 28.000 top engineers carry out studies and conception projects for the technical and information systems divisions of large corporate clients in the industrial, telecommunications and services sectors. In a fast globalising world, ALTEN integrates with the R&D strategy of its clients to support performance and partner them in breaking into new markets. ALTEN is active in 20 countries, covers the whole development cycle and offers a choice of service levels, from technology consulting to full-blown project outsourcing. It is the technology partner of choice for Europe’s leading companies.

Due to the growth of the business activity, from the International Talent Acquisition Department, we are now looking for a    Qualification and Validation Specialist to join our team in the Life and Science Industry in the German speaking part of Switzerland. 

We are looking forward to getting to know you and your ambitions!

Responsibilities

• Responsible for working with the automation team on fixture and automation system development as well as deployment into a manufacturing environment.


• Responsible for introducing and validating new equipment and/or complex new process in compliance with regulatory requirements.


• Responsible for development and management of URS, FDS, FAT, SAT, IQ/ OQ/ PQ etc.


• Responsible for qualifying and validating equipment, utilities or processes.


• Responsible for ensuring appropriate execution of SAT/ qualifications for USP/DSP parts.


• Responsible for handling non-conformities treatments by realizing all the necessary test execution protocols (IQ, OQ, PQ).


• Responsible for developing new documentation, operating procedures, and failure analysis guides.


• Responsible for qualifying and validating all the documentation.

Skills

• Minimum: Bachelor's Degree in Pharmaceutical, Chemical or related fields


• Accustomed to working in a validated environment with strong discipline regarding change control.


• Strong analytical and problem-solving skills.


• Ability to organize, plan and execute multiple tasks to tight schedules.


• Highly motivated self-starter with excellent communication skills.


• Well-developed project management skills


• Fluent in German and English