Description

For one of our clients, we are currently looking for a Computer System Validation Engineer (m/w/d) to join the Metrology and Validation Department within Analytical R&D (AR&D) in Switzerland.

Our client, based in Schachen, offers an exciting opportunity for a scientist or engineer with a background in Computer System Validation (CSV) or Equipment Qualification. The selected candidate will collaborate closely with the local site team as well as the global Metrology and Validation organization, including colleagues in the U.S. and Ireland. The role provides strong development potential, with responsibilities adapted to the candidate's experience and ambitions.
As part of the Metrology & Validation team, the Computer Systems Validation function will oversee and support the qualification of analytical instrumentation and computer systems within a GMP-regulated environment. The core responsibility of this role is to ensure that analytical laboratory instruments remain in a state of ongoing inspection readiness, while also supporting the introduction and implementation of new systems

Main areas of responsibility include:

• Coordinate and conduct equipment and instrument qualifications, and additional system lifecycle activities including. purchasing, maintenance, decommissioning, upgrades etc.
• System validation: Perform SDLC (Software 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 instruments
• Coordinate and conduct 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

Your profile::

Education:

• Completed technical apprenticeship in biotechnology, pharmaceutical industry, IT, or a related field, and/or
• Technical training in the management and maintenance of industrial equipment
• University degree in analytical chemistry, biotechnology, biochemistry, or a related scientific discipline

Experience & Skills

Required

• Excellent documentation skills and a high level of attention to detail
• Proven ability to take initiative and apply innovative problem-solving approaches in collaboration with cross-functional team members
• Daily communication and coordination with laboratory colleagues and managers regarding open tasks
• Ability to work independently as well as in cross-functional teams, while meeting deadlines in a dynamic environment
• Experience in Computer System Validation (CSV) or Commissioning & Qualification (C&Q)
• Strong oral and written communication skills in English (min. B1) and German (min. B2)

Preferred (Advantageous)

• Experience with controlled-temperature units and incubators (qualification, maintenance, calibration)
• Hands-on experience in technical support or maintenance of laboratory instruments
• Knowledge of Change Management principles and experience with Deviation/CAPA processes
• Strong affinity for technical maintenance of equipment and IT-related software solutions
• Experience in GMP-regulated environments, ideally in GMP laboratories
• Familiarity with auditing and compliance processes in the pharmaceutical industry
• Solid understanding of GMP policies and procedures, with demonstrated experience in quality-related workflows

Additional Information:

• Home office and hybrid working. This is a site-based role, 5 days per week
• Opportunity for home office is available on a need basis and in coordination with lab heads and managers
• Candidates with longer notice period can be considered
• Contract duration: asap till 31.07.2026 with an option for the extension