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Biotech NPI Technical QA - Job Opportunity at JobContax

Dublin, Ireland
Contract
Senior
Posted: April 10, 2025
Hybrid
EUR 50-58 per hour

Benefits

Hybrid work arrangement
12+ month contract duration with extension possibility
Premium hourly rate above market average
Exposure to cutting-edge biotech manufacturing

Key Responsibilities

Lead quality assurance oversight for technology transfer and new product introductions
Direct validation documentation and approval processes
Manage risk assessment and mitigation strategies
Guide cross-functional teams in process optimization
Ensure regulatory compliance and safety standards

Requirements

Education

University degree in Science or Engineering-related discipline

Experience

10+ years in pharmaceutical or biotechnology industry

Required Skills

Technical transfer expertise PPQ execution experience Lifecycle management Validation principles knowledge Regulatory requirements understanding Change control management Non-conformance resolution CAPA implementation Organizational skills Communication abilities Critical thinking Problem-solving Quality by Design (QbD) familiarity Statistical analysis tools proficiency Team collaboration
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Sauge AI Market Intelligence

Industry Trends

The biotech manufacturing sector in Ireland is experiencing significant growth, with major investments in aseptic manufacturing capabilities. This reflects a broader European trend of expanding biopharmaceutical production capacity. The focus on technical transfer and NPI indicates a strategic push towards new product development and commercialization. Increasing regulatory scrutiny in aseptic manufacturing is driving demand for experienced QA professionals.

Salary Evaluation

The hourly rate of EUR 50-58 translates to approximately EUR 104,000-120,640 annually, which is competitive for senior QA roles in the Dublin biotech sector. This range aligns with the position's strategic importance and required expertise.

Role Significance

Based on the facility scale and role scope, this position likely interfaces with a technical team of 15-20 professionals across quality, manufacturing, and validation functions.
This is a senior technical position with significant influence over product quality and manufacturing processes. The role requires independent decision-making and cross-functional leadership.

Key Projects

Technology transfer of new biotech products from development to commercial manufacturing Process Performance Qualification campaigns Validation master planning and execution Quality system enhancement initiatives Regulatory compliance programs

Success Factors

Deep understanding of aseptic manufacturing processes and controls Strong technical documentation and risk assessment capabilities Ability to influence and align cross-functional teams Excellent problem-solving skills in a GMP environment Proactive quality mindset with business acumen

Market Demand

Very High - Dublin's biotech sector is expanding rapidly, and experienced QA professionals with technical transfer expertise are in significant demand. The combination of aseptic manufacturing experience and NPI capabilities makes this role particularly sought after.

Important Skills

Critical Skills

Technical transfer expertise - Essential for successful product introductions and scale-up Quality system knowledge - Fundamental for maintaining GMP compliance Risk assessment capabilities - Critical for ensuring product quality and regulatory compliance Cross-functional leadership - Key for coordinating complex technical projects

Beneficial Skills

Statistical analysis tools proficiency Project management experience Continuous improvement methodologies Industry 4.0 technologies awareness

Unique Aspects

Opportunity to work in one of Ireland's premier aseptic manufacturing facilities
Involvement in cutting-edge biotech product transfers
Exposure to latest aseptic processing technologies
Significant professional development potential in rapidly growing facility

Career Growth

2-4 years in role typically required before advancement to director-level positions

Potential Next Roles

Quality Director Technical Operations Manager Validation Head Quality Systems Manager Manufacturing Science and Technology Lead

Company Overview

JobContax

The facility represents a significant investment in Ireland's biotech manufacturing capability, with state-of-the-art aseptic processing technology.

Leading position in biotech manufacturing with substantial growth trajectory and capital investment
Strategic importance in European biotech manufacturing network with significant local economic impact
Dynamic, fast-paced environment focused on technical excellence and regulatory compliance
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