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Sr. Engineer Process Development - Job Opportunity at Amgen

Dún Laoghaire, Ireland
Full-time
Senior
Posted: April 13, 2025
On-site
EUR 85,000 - 110,000 annually based on Dublin biotech market rates and senior position requirements

Benefits

Competitive industry compensation package
Career development in biotech leadership
Global exposure and networking opportunities
Advanced technical training and development
Opportunity for international mobility within Amgen network

Key Responsibilities

Lead technical expertise delivery for sterile drug product operations including formulation, vial filling, and lyophilization
Drive strategic process investigations and root cause analysis impacting product quality
Serve as key technical decision maker for change control and process modifications
Spearhead new product introductions and protocol development
Lead continuous improvement initiatives for manufacturing excellence
Conduct advanced data analysis for process optimization
Oversee GMP documentation and compliance standards
Direct cross-functional collaboration for global product strategies

Requirements

Education

Bachelor's or Masters degree in Engineering, Science or related discipline OR PhD

Experience

6 years with Bachelor's/Master's OR 4 years with PhD

Required Skills

Drug product formulation expertise Sterile manufacturing knowledge GMP compliance understanding Technical leadership capabilities Cross-functional team management Problem-solving abilities Risk assessment competency Data analysis proficiency
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on biologics and complex drug delivery systems is driving demand for specialized process engineering expertise Growing emphasis on continuous manufacturing processes in pharmaceutical production requires advanced technical leadership Rising regulatory scrutiny in sterile manufacturing creates premium for experienced process engineers Industry shift towards automated and digitalized manufacturing processes demands hybrid technical-digital skill sets

Role Significance

Typically leads or influences 5-8 direct reports with matrix responsibility across multiple functions
Senior technical leadership position with direct impact on product quality and manufacturing efficiency

Key Projects

New product technology transfer and scale-up initiatives Manufacturing process optimization and validation programs Regulatory compliance and audit preparation activities Cross-site harmonization projects

Success Factors

Deep technical expertise in sterile drug product manufacturing Ability to balance technical excellence with business objectives Strong risk assessment and decision-making capabilities Excellence in cross-functional leadership and stakeholder management Proactive problem-solving mindset with focus on continuous improvement

Market Demand

High demand with significant growth trajectory due to expanding biologics manufacturing sector and limited talent pool with specialized sterile processing expertise

Important Skills

Critical Skills

Sterile manufacturing expertise - Essential for ensuring product quality and compliance Technical leadership - Critical for driving process improvements and team development GMP knowledge - Fundamental for maintaining regulatory compliance Problem-solving capabilities - Core to role success in complex manufacturing environment

Beneficial Skills

Project management certification Six Sigma methodology knowledge Digital manufacturing systems expertise Change management experience

Unique Aspects

Opportunity to work with cutting-edge biotech manufacturing processes
Exposure to global networks and best practices
Significant role in shaping future manufacturing capabilities
Balance of technical leadership and strategic business impact

Career Growth

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

Potential Next Roles

Drug Product Technical Director Manufacturing Site Lead Global Process Excellence Leader Technical Operations Director

Company Overview

Amgen

Amgen is a global biotechnology leader focused on developing innovative human therapeutics

Top-tier biopharmaceutical company with strong market position and continuous growth trajectory
Strategic European manufacturing hub with significant investment in Irish operations
Innovation-driven environment with strong emphasis on technical excellence and professional development
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