CSV engineer (M/W/D) 100%
- Entreprise
- Tech'Firm Industrie AG
- Lieu
- Zürich
- Date
- 07.05.2025
- Référence
- 102145
Join Our Team in Switzerland
We invite skilled professionals to explore new challenges with us in our Techfirm Industrial Services team.
Your Responsibilities
As a key contributor, you will play a pivotal role in the Computer System Validation (CSV) activities for the Technical Services department, ensuring compliance with both internal and external standards.
Major Interfaces
- Technical Services
- All onsite departments relying on CSV services
Key Objectives
- Oversee that validation phases are executed in alignment with global and local policies, legal requirements, and regulatory mandates.
- Ensure Validation Master plans are updated and tailored for all ongoing projects.
Essential Duties
- Plan, coordinate, and execute all phases of computer system validation for production and quality control lab systems, including the creation of validation plans, FMEA, RTM, DQ, IQ, OQ, and PQ test scripts.
- Prepare, review, and approve technical and GMP-related documentation such as User Requirement Specifications (URS), impact/risk assessments, and qualification/validation documentation.
What You Bring
- Bachelor's or master's degree in technical or natural sciences.
- A minimum of 3 years of experience within the pharmaceutical or biotech industry.
- Proven experience in validating computerized manufacturing and complex analytical laboratory equipment.
- Exceptional written and verbal communication skills in English; proficiency in additional languages is advantageous.
- Knowledge of cGMP and regulatory requirements.
- Experience working in Europe/Switzerland is preferred.
About Us
TechFirm is a Swiss-based engineering company established in 1998, with offices in Geneva, Fribourg, Basel, and Zurich, comprised of a dynamic team of 350 dedicated engineers. We operate across various sectors including Life-Sciences, Chemistry, Energy, Construction, Transport, and Watchmaking.
Our Industrial Services division focuses on all phases of industrial investment projects, from concept and basic engineering to execution support and maintenance, ensuring excellence and performance throughout the process.
At TechFirm, we foster a vibrant, supportive, and dynamic work environment, encouraging everyone to thrive and feel fulfilled in their roles. We pride ourselves on being a human-centric organization.
Please note: We can only consider applicants who are Swiss or EU/EFTA nationals or hold a valid residence or work permit for Switzerland.