Career

Partnership is the core of our business culture. We strive to be the best partner for our clients now and in the future. First and direct contact with our clients demands from us to be team players. We are open, flexible and creative professionals who deal actively with the challenges that arise and provide the solutions to them. An eagerness to learn and grow is fundamental to our organization’s success.

Responsibility, honesty, respect and diversity are the values we believe in and live by in our company, PiQuP AG team.

At PiQuP we care about sustainability and social responsibility. PiQuP AG is the sponsor of the youth teams of FC Diessenhofen and Schaffhausen Rugby Club.

 

Open Positions

CSV-Engineer 80-100%

We are looking for dedicated new colleagues to expand our team and enhance our services.
Become part of our specialized team and experience how new technologies in the field of aseptic manufacturing are developed, designed, and qualified. Send your application to job-application@piqup.ch.

Main Responsibilities

  • Erstellung von Inbetriebnahme- und Validierungsdokumenten für neue Systeme sowie Begleitung von Umbau-, Erweiterungs- und Neubauprojekten. Dies umfasst CSV-Aktivitäten für kritische Systeme sowie SLC-Support nach der InbetriebnahmePreparation of commissioning and validation documents for new systems, as well as support for conversion, expansion, and new construction projects. This includes CSV activities for critical systems and SLC support after commissioning.
  • Installation and configuration of the software according to the installation protocol (if necessary, clarification of the installation, troubleshooting, and preparation of the protocol).
  • Setting up backups.
  • Planning, coordination, and implementation of CSV activities in close collaboration with our customers and their suppliers.
  • Monitoring and processing of deviations, changes (GEP and GMP), and CAPAs. Review and optimize existing CSV documents such as SOPs and templates
  • Further development of CSV strategies for our customers
  • Maintenance and continuous improvement of our internal CSV templates

Your Profile

  • Completed degree (computer science, life sciences, engineering) or equivalent professional experience
  • Experience in software installation/configuration, software troubleshooting, backup/restore processes
  • Experience with CSV in a GMP-regulated environment (pharmaceutical or medical device)
  • Knowledge of relevant guidelines (Swissmedic, FDA, EU GMP), project and lifecycle management, as well as quality assurance and risk management
  • Analytical thinking, high attention to detail, and a structured approach
  • Initiative, team spirit, and strong communication skills
  • Very good written and spoken German and English skills
  • Experience with the validation of laboratory equipment
  • Knowledge or application experience with Kneat
  • Additional certification in CSV

We offer

  • A dedicated, growing team with a high level of High standards of quality
  • Exciting projects at leading pharmaceutical companies
  • The opportunity to actively participate in the future of digital validation processes
  • Personal development and independent work

Qualification Engineer

We are looking for qualification engineer to join our team and expand our services. Become a member of our specialized team and experience how the new technologies in aseptic manufacturing are developed, constructed, and qualified. Please send your application to job-application@piqup.ch.

Main Responsibilities

  • supervision of qualification activities for various big pharma companies ensuring GMP and technical compliance
  • issue and verification of machine documentation, procedures and Life-Cycle documentation
  • issue of parent qualification documentation
  • installation and functional testing of modern equipment together with clients and suppliers
  • implementation and integration of paperless qualification system together with our software partner
  • analysis of the paper based processes, creation of concepts, document templates and document packages for paperless processes in cloud based software environment
  • preparation of PMD (Process Mapping Document), training material, conducting of training and support
  • advice and assistance for questions and subsequent changes
  • support activities in quality assurance: contact person for QA, production and engineering department regarding production and infrastructure equipment

Your Profile

  • completed technical education or studies in Engineering or Life Science
  • work experience in Pharma or Medical Device industry (plus)
  • customer-oriented working style
  • self-starter with good interpersonal skills
  • attention to detail and willingness to learn
  • very good knowledge of German and English, both written and spoken
  • team player

We offer

  • flat organisation structure with pleasant working environment
  • great potential for growing and further development in various areas of pharma industry and digitalization of validation processes
  • above average compensation package
  • regular training and team building events