Computer System Validation Engineer​/Ingenieur; P2 level

Client Description

We are currently assisting our client, a global leader in biopharmaceuticals, in their search for a Technician Clinical Packaging to join their team in Schachen, Lucerne (LU), Switzerland. The company is committed to developing innovative therapies that improve patients' quality of life and save lives.

• Coordinate and conduct equipment and instrument qualifications, and additional system lifecycle activities including purchasing, validation, maintenance, decommissioning and upgrades.
• Perform system validation (SDLC) in cooperation with IT and the Validation unit of the site.
• Collaborate with the site Laboratory Asset Management Program (LAMP) to ensure calibration and maintenance services are scheduled in accordance with documented due dates or ad‑hoc as required to support business needs.
• Support site‑wide projects and initiatives directly related to Metrology & Validation and/or AR&D.

• Coordinate with cross‑functional teams to qualify new equipment and validate computerised instruments.
• Coordinate and where required support execution of maintenance and calibration of analytical equipment.
• Check and evaluate potential alarms of controlled‑temperature units (e.g. stability chambers) and laboratory 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 time between 7:00 and 8:45 am.

• This is a site‑based role, 5 days per week.
• Opportunity for home office available on a need basis and in coordination with lab heads and managers.

Education:

candidate could have one of the following:

• Technical education (Apprenticeship) in Biotech, Pharmaceutical industry, IT or related areas.
• Technical education in management and maintenance of industrial equipment.
• University degree in analytical chemistry, biotechnology, biochemistry or related field.

• Required:
  • 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 such as HPLC, qPCR, assay plate readers.
• Advantage:
  • Experience with project management methodologies, software, or tools.
  • Experience with controlled‑temperature units and incubators, e.g. qualification, maintenance, calibration.
  • Experience as technical support and maintenance of laboratory instrumentation.
  • Experience with change management principles 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.