Computer System Validation Engineer (P2 level)
Headhunter: LHH
Pharmaceutical Industry
Luzern - Schweiz
Senior Specialist / Project Manager
Hybrid
Experteer Overview
In this role you will support the qualification and validation of analytical equipment and computer systems within a GMP setting, ensuring ongoing inspection readiness. You will align with global Metrology & Validation teams to drive calibration, maintenance and system lifecycle activities. The work involves cross-functional collaboration to qualify instruments, support site projects, and author controlled documents. This is a hands-on role with growth potential in a global biopharma environment.
Responsibilites
- Coordinate and conduct equipment and instrument qualifications and system lifecycle activities
- Perform SDLC validation in cooperation with IT and site Validation unit
- Schedule calibration maintenance for analytical equipment with LAMP coordinators
- Coordinate maintenance, calibration, and qualification activities for analytical instruments
- Support site-wide Metrology & Validation and AR&D projects
- Qualify new equipment and validate computerised instruments with cross-functional teams
- Provide initial troubleshooting for analytical instruments
- Author SOPs, change controls, and period review documents for equipment and instruments
- Author and support deviation investigations
Key requirements
- English (B1) and German (B2) proficiency
- Strong documentation skills and attention to detail
- Proactive, innovative problem-solving and collaboration
- Ability to work independently and in cross-functional teams to meet timelines
- Experience with CSV or commissioning/qualification
- Experience with analytical instruments (HPLC, qPCR, assay plate readers)
Description
In this role you will support the qualification and validation of analytical equipment and computer systems within a GMP setting, ensuring o…
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