<br />Hast du Erfahrung als CSV Experte mit fundiertem Wissen in Prozessleitsystemen (PLS) im Pharma GMP-Umfeld?<br />Wenn ja, ist dieses Projekt genau das Richtige für dich!<br /><br /><br />Allgemeine Informationen:<ul><li>Startdatum: asap</li><li>Spätestmögliches Startdatum: 01.08.2026</li><li>Geplante Dauer der Anstellung: 12 Monate</li><li>Verlängerung: wahrscheinlich</li><li>Workload: 40–60 % (je nach Erfahrung des Kandidaten)</li><li>Home Office: Nein</li><li>Reisen: Nein</li><li>Team: 10 Personen</li><li>Arbeitszeiten: Standard</li></ul><br />Aufgaben & Verantwortlichkeiten:<ul><li>CSV-Dokumentation: Federführende Erstellung der validierungskonformen User Requirements Specifications (URS) sowie der funktionalen Spezifikationen (FS) unter Berücksichtigung der GxP / CSV Richtlinien.</li><li>Solutioning & Compliance: Sicherstellen, dass die Umsetzung der Validierungsaktivitäten für das Prozessleitsystem den CSV-Anforderungen gerecht wird.</li><li>Ausführungsplanung: Erstellen einer Roadmap und eines detaillierten Terminplans für die Ausführung und Validierung.</li><li>Überwachung der Ausführung: Sicherstellen, dass die Anforderungen in der geforderten Qualität, in den vorgegebenen Timelines und unter Einhaltung der CSV- Standards umgesetzt werden.</li><li>Schnittstelle: Agieren als Koordinator zwischen Technischer Compliance und den ausführenden Teams.</li></ul><br />Must Haves:<ul><li>Ausbildung/Studium idealerweise als Automatisierungsingenieur oder vergleichbares</li><li>Mindestens 10 Jahre Erfahrung im Bereich CSV (Computerized System Validation) im Pharma GMP-Umfeld </li><li>Nachweisbare Erfahrung mit Prozessleitsystemen (PLS) oder ähnlichen Automatisierungssystemen in der Produktion </li><li>Nachweisbare Erfahrung in der Erstellung von validierungskonformen URS und Spezifikationen (GxP / CSV) </li><li>Sehr gute IT/ Tool-Kenntnisse, insbesondere in Bezug auf Dokumentations- und Workflow-Tools für die Validierung </li><li>Englisch (gute Kenntnisse)</li></ul><br />Wir danken Dir für Deine Bewerbung!

<p>For one of our clients, an international pharmaceutical company, we are seeking a Computer System Validation Engineer.</p><p>General Information:</p><ul><li>Start date: 01.05.2026</li><li>End Date: 31.10.2026</li><li>Workplace: Schachen, Luzern</li><li>Home office: No, 100% onsite, 5 days per week (home office is available on a need basis and in coordination with lab heads and managers)</li><li>Workload: 100%</li><li>Working hours: Standard</li></ul><p>About the work:</p><p>Our client’s Metrology and Validation department in Analytical R&D (AR&D), located in Schachen, is currently looking for a scientist or engineer with a background in Computer System Validation (CSV) or Equipment Qualification. The candidate will work at the local site and in alignment with our global Metrology and Validation team, with our counterparts in the U.S., and Ireland. The position offers development potential and responsibilities can be adjusted to the candidate’s qualifications and ambitions.</p><p>The Metrology & Validation team has oversight of all laboratory instrumentation and equipment, providing daily hands-on support, oversight of scheduled maintenance/calibrations and the qualification of new analytical instrumentation and Computer Systems projects within a GMP environment. Responsibility of this function is to maintain the analytical laboratory instruments and implement new systems in a state of permanent inspection readiness.</p><p>Tasks & responsibilities:</p><ul><li>Provide day-to-day support and troubleshooting of issues relating to laboratory instruments and equipment.</li><li>Coordinate and conduct equipment and instrument qualifications, and additional system lifecycle activities including. purchasing, validation, maintenance, decommissioning, upgrades etc.</li><li>System validation: Support SDLC (System development life cycle) validation in cooperation with IT and the Validation department.</li><li>Analytical Metrology: Together with the site Laboratory Asset Management Program (LAMP) coordinators, ensure calibration maintenance services are scheduled in accordance with documented due dates or ad-hoc as required to support business needs</li><li>Support site-wide projects and initiatives directly related to Metrology & Validation and/or AR&D</li></ul><p>Profile of the candidate:</p><p>Education – candidate could have one of the following:</p><ul><li>Technical education (Apprenticeship) in Biotech, Pharmaceutical industry, IT or related areas</li><li>Technical education in management and maintenance of industrial equipment</li><li>University degree, in analytical chemistry/biotechnology/biochemistry or related field</li></ul><p>Experience and skills:</p><ul><li>Strong oral and written communication skills in English (B1) and German (B2)</li><li>Strong documentation skills on technical documents, attention to detail</li><li>Demonstrated ability for taking initiative and innovative problem solving in collaboration</li><li>with other team members</li><li>Daily communication and coordination with laboratory colleagues and managers on open tasks</li><li>Ability to work independently and within a cross-functional team to deliver on timelines in a dynamic environment</li><li>Experience with CSV (must have) or Commissioning/Qualification experience considered if relevant</li><li>Experience with analytical laboratory instruments i.e. HPLC, qPCR, assay Plate Readers</li></ul><p>Nice to haves:</p><ul><li>Experience with project management methodologies, software, or tools</li><li>Experience with controlled-temperature units and incubators, i.e. qualification, maintenance, calibration</li><li>Experience as technical support and maintenance of laboratory instrumentation</li><li>Experience with Change Management principals and Deviation/CAPA management</li><li>Affinity for technical maintenance of equipment and IT related software</li><li>Experience in GMP environment, especially in GMP laboratories</li><li>Experience in Auditing and Compliance within the pharmaceutical industry</li><li>Thorough understanding of GMP policies and procedures and proven experience working with Quality</li></ul><p>Sounds interesting? Apply now – we’re looking forward to receiving your applications!</p>