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Aseptic Processing Validation Manager - Job Opportunity at Amgen

Dublin, Ireland
Full-time
Senior
Posted: January 29, 2025
On-site
EUR 90,000 - 120,000 per year based on Dublin biotech market rates and senior management level

Benefits

Competitive pharmaceutical industry compensation package
Professional development opportunities in validation and regulatory compliance
Growth within a leading biotech organization
Exposure to cutting-edge aseptic processing technologies

Key Responsibilities

Lead and manage HVAC/AVS/APS validation team with strategic oversight of sterilization and aseptic processing systems
Direct validation programs ensuring regulatory compliance and operational efficiency
Oversee aseptic process simulation program including intervention reviews and protocol management
Manage regulatory filings and quality system maintenance
Drive team development and succession planning while maintaining operational excellence

Requirements

Education

Master's degree with 5+ years of experience in validation, engineering or BS degree with 7+ years of experience in Validation, Engineering, Microbiology or Quality

Experience

7+ years with BS or 5+ years with Masters

Required Skills

cGxP knowledge Sterilisation/decontamination systems expertise HVAC systems qualification Program and change management Critical thinking and analytical skills Interpersonal and communication skills Budget management Technical validation expertise Regulatory compliance knowledge
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on advanced aseptic processing technologies due to growing biological drug manufacturing Heightened regulatory scrutiny in aseptic manufacturing driving demand for validation expertise Integration of automation and digital systems in aseptic processing creating need for hybrid technical-quality skill sets

Role Significance

Typically manages 5-8 direct reports with additional contract personnel oversight
Senior management position with direct impact on product quality and regulatory compliance

Key Projects

Aseptic processing validation programs Regulatory compliance initiatives Quality system improvements Validation master plan development Team development and operational excellence programs

Success Factors

Deep technical knowledge in aseptic processing and validation Strong regulatory understanding and compliance focus Excellent people management and leadership capabilities Ability to balance technical excellence with operational efficiency Strategic thinking and problem-solving skills

Market Demand

High demand position due to complex technical requirements and critical role in biological drug manufacturing compliance

Important Skills

Critical Skills

Validation expertise - Essential for ensuring product quality and regulatory compliance Leadership capabilities - Critical for team development and program success Technical knowledge - Fundamental for understanding complex aseptic processes Regulatory understanding - Vital for maintaining compliance and managing inspections

Beneficial Skills

Project management - Valuable for coordinating multiple validation programs Change management - Important for implementing process improvements Business acumen - Helpful for budget management and resource allocation

Unique Aspects

Combination of technical leadership and people management in critical manufacturing environment
Direct impact on product quality and patient safety
Exposure to cutting-edge aseptic processing technologies

Career Growth

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

Potential Next Roles

Director of Validation Head of Technical Operations Quality Systems Director Site Technical Director

Company Overview

Amgen

Amgen is a leading global biotechnology company focused on developing innovative human therapeutics

Top-tier biopharmaceutical company with strong market presence and continuous growth
Strategic European manufacturing hub with significant investment in Ireland operations
High-performance, quality-focused environment with emphasis on technical excellence and regulatory compliance
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