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Quality Engineer - Job Opportunity at Cytiva

Medemblik, Netherlands
Full-time
Mid-level
Posted: April 24, 2025
On-site
EUR 55,000 - 75,000 annually based on location and market conditions in the Netherlands biotech sector

Benefits

Advanced biotech industry exposure
Global career development opportunities across 40+ countries
Continuous learning and development programs
Work on life-changing therapeutic solutions
Part of Danaher corporation offering competitive benefits package

Key Responsibilities

Lead quality assurance for validated state of products, processes, methods and equipment
Manage quality aspects of plant-wide projects and R&D initiatives
Oversee validation documentation for gamma irradiation and product sterility
Coordinate validation activities with laboratory contractors
Support customer certification requests and maintain quality documentation
Implement and maintain process control systems including FMEA

Requirements

Education

Master in a scientific field, preferable in Lifesciences (bio, biomedical, chemical, pharma)

Experience

3+ years

Required Skills

Analytical mind and data analysis Problem-solving capabilities Knowledge of ISO 9001 and ISO 13485 English (written & spoken) Dutch language proficiency Root Cause analysis QMS Validation processes
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Sauge AI Market Intelligence

Industry Trends

The biotechnology sector is experiencing rapid growth driven by increased demand for innovative therapeutics and vaccines, particularly in cell and gene therapy areas. Quality engineering roles in biotech are becoming increasingly strategic as regulatory requirements become more complex and manufacturing processes more sophisticated. The integration of digital tools and data analytics in quality management is creating new opportunities for process optimization and compliance tracking.

Role Significance

Typically part of a quality team of 5-10 professionals, working cross-functionally with R&D, manufacturing, and regulatory affairs
Mid to senior-level position with significant project leadership responsibilities and direct impact on product quality and regulatory compliance

Key Projects

Implementation and validation of new therapeutic manufacturing processes Quality system optimization and compliance programs Cross-functional R&D project quality leadership Regulatory documentation and certification management

Success Factors

Strong technical expertise in quality management systems and regulatory standards Ability to balance multiple stakeholder requirements while maintaining quality standards Effective communication skills for cross-functional collaboration and customer interaction Strategic thinking to anticipate and address quality challenges in new product development

Market Demand

High demand with strong growth trajectory due to expanding biotech manufacturing presence in Europe and increasing focus on quality systems in therapeutic development

Important Skills

Critical Skills

Quality management system expertise - Essential for maintaining regulatory compliance and product safety Technical understanding of bioprocessing - Critical for process validation and improvement Project management capabilities - Necessary for leading cross-functional quality initiatives Communication skills - Vital for stakeholder management and regulatory interactions

Beneficial Skills

Digital quality management tools Statistical process control Risk management methodologies Change management expertise

Unique Aspects

Direct involvement in cutting-edge therapeutic development
Combination of traditional quality engineering with biotech innovation
Global exposure through multinational projects
Opportunity to impact healthcare outcomes through quality systems

Career Growth

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

Potential Next Roles

Senior Quality Engineer Quality Manager Validation Manager Quality Director Regulatory Affairs Manager

Company Overview

Cytiva

Cytiva, part of Danaher Corporation, is a leading global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics

Major player in bioprocessing and life sciences tools market with strong presence in therapeutic development and manufacturing
Strategic location in Netherlands adds to European biotech hub presence with significant R&D and manufacturing capabilities
Innovation-driven environment with strong focus on continuous improvement and global collaboration
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