Computer System Validation Engineer

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  • Schachen, Luzern
  • Befristet
  • Vollzeit
  • 16 Tage her
For one of our clients, an international pharmaceutical company, we are seeking a Computer System Validation Engineer.General Information:
  • Start date: 01.05.2026
  • End Date: 31.10.2026
  • Workplace: Schachen, Luzern
  • Home office: No, 100% onsite
  • Workload: 100%
  • Working hours: Standard
About the work: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.The Computer Systems Validation role in the Metrology & Validation department, will oversee and support the qualification of 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.Tasks & responsibilities:
  • Coordinate and conduct equipment and instrument qualifications, and additional system lifecycle activities including. purchasing, validation, maintenance, decommissioning, upgrades etc.
  • System validation: Perform SDLC (System development life cycle) validation in cooperation with IT and the Validation unit of the site
  • 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 needsds
  • Support site-wide projects and initiatives directly related to Metrology & Validation and/or AR&D
Day in the job:
  • Coordination with cross-functional teams to qualify new equipment and validate computerized instruments
  • Coordinate and where required support execution of maintenance and calibration of analytical equipment
  • Check and evaluate potential alarms of controlled-temperature units (i.e. stability chambers) and Lab equipment
  • Provide initial troubleshooting for issues with analytical instruments in the laboratory
  • Author SOPs, Change controls, and period review documents for equipment and instruments
  • Author and Support deviation investigations
  • Typical start date between 7:00 and 8:45 am
Requirements:
  • Technical education (Apprenticeship) in Biotech, Pharmaceutical industry, IT or related areas or Technical education in management and maintenance of industrial equipment
  • University degree, in analytical chemistry/biotechnology/biochemistry or related field
  • Strong oral and written communication skills in English (B1) and German (B2)
  • Strong documentation skills on technical documents, attention to detail
  • Demonstrated ability for taking initiative and innovative problem solving in collaboration with other team members
  • Daily communication and coordination with laboratory colleagues and managers on open tasks
  • Ability to work independently and within a cross-functional team to deliver on timelines in a dynamic environment
  • Experience with CSV (must have) or Commissioning/Qualification experience considered
  • Experience with analytical instruments i.e. HPLC, qPCR, assay Plate Readers
Nice to have:
  • Experience with project management methodologies, software, or tools
  • Experience with controlled-temperature units and incubators, i.e. qualification, maintenance, calibration
  • Experience as technical support and maintenance of laboratory instrumentation
  • Experience with Change Management principals and Deviation/CAPA management
  • Affinity for technical maintenance of equipment and IT related software
  • Experience in GMP environment, especially in GMP laboratories
  • Experience in Auditing and Compliance within the pharmaceutical industry
  • Thorough understanding of GMP policies and procedures and proven experience working with Quality
Sounds interesting? Apply now – we’re looking forward to receiving your applications!

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