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MSAT-Qualifizierungs- und Validierungsingenieur - Job Opportunity at Roche Diagnostics Schweiz AG

Rotkreuz, Switzerland
Temporary
Mid-level
Posted: March 18, 2025
Hybrid
CHF 90,000 - 120,000 annually based on Swiss market rates for validation engineers in medical device sector

Benefits

Professional development funding with comprehensive training opportunities
Year-round premium retail discounts across 200+ top brands
Fleet discounts on new vehicle purchases and fuel card savings program
On-site parking facilities subject to qualification
Flexible hybrid work arrangement with 2 days remote option

Key Responsibilities

Lead qualification and validation processes for critical diagnostic systems and equipment
Conduct and moderate comprehensive risk analyses to ensure regulatory compliance
Serve as primary compliance consultant for qualification and validation requirements
Manage deviation investigations and implement corrective actions
Coordinate and support regulatory audits to maintain quality standards

Requirements

Education

Bachelor's or Master's degree in Natural Sciences or Engineering

Experience

Minimum 1 year in regulated environment with equipment qualification

Required Skills

Risk analysis expertise Quality documentation proficiency Fluent German language skills Very good English language skills Strong quality consciousness
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Sauge AI Market Intelligence

Industry Trends

Increasing regulatory scrutiny in medical diagnostics is driving higher demand for validation specialists, particularly in European markets where regulations are becoming more stringent. Digital transformation in healthcare is creating new validation challenges and opportunities, especially in automated diagnostic systems. Growing focus on risk-based approaches in validation processes is reshaping role requirements and methodologies.

Role Significance

Typically part of a 5-8 person MSAT team, collaborating with broader quality and engineering departments
Mid-level position with significant operational impact and quality assurance responsibility

Key Projects

Implementation of new diagnostic equipment validation protocols Risk analysis and compliance documentation for medical device manufacturing Regulatory audit preparation and response management

Success Factors

Strong technical foundation combined with regulatory compliance expertise Excellent documentation and communication skills across multiple languages Ability to balance quality requirements with operational efficiency Strategic thinking in risk assessment and mitigation planning

Market Demand

High demand driven by expanding regulatory requirements and technological advancement in medical diagnostics

Important Skills

Critical Skills

Validation methodology expertise essential for maintaining regulatory compliance Risk analysis capabilities crucial for product safety and regulatory approval Bilingual proficiency necessary for international documentation and communication

Beneficial Skills

Project management skills for coordinating validation activities Knowledge of emerging diagnostic technologies Understanding of GMP and ISO standards in medical device industry

Unique Aspects

Combination of traditional validation requirements with emerging diagnostic technologies
Strong focus on language skills indicating significant international collaboration
Temporary position with extension possibility suggesting project-based strategic initiatives

Career Growth

2-3 years in role typically required before advancement to senior positions

Potential Next Roles

Senior Validation Engineer Quality Assurance Manager Regulatory Compliance Manager Validation Team Lead

Company Overview

Roche Diagnostics Schweiz AG

Roche Diagnostics is a global leader in in-vitro diagnostics and tissue-based cancer diagnostics, operating at the forefront of personalized healthcare

Industry leader with strong market position in diagnostic solutions and significant R&D investment
Strategic location in Rotkreuz serves as a key hub for European operations
Professional environment with strong focus on innovation and quality, typical of Swiss pharmaceutical industry standards
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