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S&C MSAT Qualification and Validation Engineer - Job Opportunity at FLEXSIS

Rotkreuz, Switzerland
Full-time
Mid-level
Posted: March 18, 2025
On-site
CHF 85,000 - 110,000 per year based on Swiss market rates for validation engineers with similar experience requirements

Benefits

Preferred supplier partnership with Roche Diagnostics indicating stable project pipeline
Permanent position offering job security
Work with cutting-edge pharmaceutical manufacturing equipment
Professional development in GMP environment

Key Responsibilities

Lead equipment qualification processes for pharmaceutical manufacturing systems including risk analysis and deviation management
Coordinate and execute process and method validations including requalification activities
Serve as subject matter expert for qualification and validation compliance
Drive stakeholder communication and project collaboration
Support deviation management in S&C sensor and reagent production
Ensure regulatory compliance and standard adherence

Requirements

Education

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

Experience

Minimum 1 year in regulated environment and equipment qualification

Required Skills

Equipment qualification expertise Process validation knowledge Risk analysis competency Technical understanding Quality documentation experience Independent work style Team collaboration German fluency (C-level) English proficiency (B2)
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on automation and digitalization in pharmaceutical manufacturing validation processes Growing demand for MSAT engineers due to expanding biotech and pharmaceutical production in Switzerland Rising importance of data integrity and electronic validation systems in GMP environments Trend towards integrated qualification approaches combining equipment and process validation

Role Significance

Typically part of a 5-10 person MSAT team, working within a larger manufacturing support organization
Mid-level position with significant technical responsibility and stakeholder interaction, serving as a subject matter expert for validation activities

Key Projects

Equipment qualification programs for new manufacturing systems Process validation campaigns for pharmaceutical production Compliance improvement initiatives Manufacturing deviation investigations and resolutions

Success Factors

Strong technical foundation combined with GMP understanding Excellent documentation and risk analysis capabilities Ability to manage multiple stakeholders and drive consensus Detail-oriented approach while maintaining project progress Effective communication skills in both German and English

Market Demand

High demand due to expanding pharmaceutical manufacturing sector in Switzerland and increasing regulatory requirements for validation

Important Skills

Critical Skills

Equipment qualification expertise - Essential for core job functions and regulatory compliance Risk analysis capabilities - Critical for modern validation approaches GMP understanding - Fundamental for pharmaceutical manufacturing environment Technical documentation skills - Key for validation activities and compliance

Beneficial Skills

Project management skills - Valuable for coordination of validation activities Statistical analysis capabilities - Useful for process validation Change management experience - Helpful for implementation of new procedures Automation system knowledge - Increasingly important in modern manufacturing

Unique Aspects

Direct involvement with Roche Diagnostics operations
Combination of equipment and process validation responsibilities
Opportunity to work with advanced pharmaceutical manufacturing systems
Position at intersection of technical and regulatory requirements

Career Growth

2-4 years in role before advancement, depending on project success and organizational growth

Potential Next Roles

Senior Validation Engineer Validation Team Lead Quality Systems Manager Manufacturing Technical Support Manager

Company Overview

FLEXSIS

FLEXSIS operates as a preferred supplier for Roche Diagnostics, providing specialized technical personnel for critical manufacturing support functions

Strategic partner to major pharmaceutical companies with focus on technical staffing and consulting
Strong presence in Swiss pharmaceutical hub, particularly in central Switzerland
Professional consulting environment with direct client interaction and focus on technical excellence
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