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CSV Engineer - Job Opportunity at Oxford Global Resources

Leiden, Netherlands
Temporary
Mid-level
Posted: May 19, 2025
Hybrid
EUR 40,800 - 84,000 per year

Benefits

Hybrid work environment offering flexibility and work-life balance
International exposure in cutting-edge biotech sector
Professional development opportunities in advanced cell therapy field
Modern facility with state-of-the-art equipment

Key Responsibilities

Lead equipment quality assurance initiatives in advanced cell therapy production, directly impacting patient treatment outcomes
Drive regulatory compliance through comprehensive documentation management and technical review processes
Spearhead risk assessment programs and implement corrective action strategies
Coordinate cross-functional quality initiatives with technical teams
Manage equipment lifecycle documentation and validation processes
Direct audit preparation and regulatory inspection processes

Requirements

Education

Bachelor's or Master's degree in technical or life sciences discipline

Experience

Minimum 3 years in pharmaceutical or medical manufacturing

Required Skills

cGMP and ISO 13485 regulatory knowledge Equipment qualification expertise Quality process management Veeva and TrackWise proficiency CSV implementation experience Automation systems knowledge Lean methodology understanding Laboratory equipment familiarity
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Sauge AI Market Intelligence

Industry Trends

The cell therapy sector is experiencing rapid growth with a CAGR of 14.5% through 2027, driving increased demand for quality specialists with CSV expertise. Point-of-care cell therapy manufacturing is emerging as a revolutionary approach, requiring specialized quality management skills. Regulatory complexity in cell therapy is intensifying, particularly in EU markets, making CSV expertise increasingly valuable.

Salary Evaluation

The offered salary range aligns with market standards for biotech quality specialists in the Netherlands, with potential for upward adjustment based on CSV expertise

Role Significance

Typically part of a 5-8 person quality team in biotech manufacturing settings
Mid-level specialist role with significant autonomy in quality management decisions

Key Projects

Implementation of new equipment validation protocols for cell therapy production Development of quality management systems for point-of-care manufacturing Regulatory compliance initiatives for EU and FDA requirements

Success Factors

Strong understanding of GMP requirements in cell therapy manufacturing Ability to bridge quality systems with practical manufacturing needs Excellence in technical documentation and regulatory interpretation Proactive problem-solving approach in quality management

Market Demand

High demand with limited talent pool, particularly for candidates combining CSV expertise with cell therapy experience

Important Skills

Critical Skills

CSV expertise is fundamental for ensuring compliant equipment validation GMP knowledge is essential for maintaining regulatory standards in cell therapy production Technical documentation skills are crucial for regulatory compliance

Beneficial Skills

Lean methodology understanding can optimize quality processes Automation systems knowledge supports future facility scaling Experience with specific quality tools (Veeva, TrackWise) enhances efficiency

Unique Aspects

Direct involvement in revolutionary point-of-care cell therapy manufacturing
Opportunity to shape quality systems in an emerging therapeutic approach
Combination of traditional CSV requirements with innovative manufacturing methods

Career Growth

2-3 years in role before advancement, depending on project success and regulatory expertise development

Potential Next Roles

Senior Quality Manager Validation Program Lead Quality Systems Director Cell Therapy Manufacturing Manager

Company Overview

Oxford Global Resources

An innovative biotechnology organization pioneering point-of-care cell therapy solutions

Emerging player in the cell therapy sector with unique hospital-based manufacturing approach
Strategic presence in South Holland's biotech corridor with potential for European expansion
Dynamic, innovation-focused environment with emphasis on technical excellence and regulatory compliance
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