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Process Development Engineer - Job Opportunity at Amgen

Dún Laoghaire, Ireland
Full-time
Mid-level
Posted: July 12, 2025
On-site
Based on the mid-level experience requirements and Amgen's position as a leading biopharmaceutical company, this role likely offers compensation in the range of €70,000-€90,000 annually, with potential for additional benefits and performance bonuses typical of multinational pharmaceutical companies operating in Ireland's competitive market.

Benefits

International travel opportunities across European contract manufacturing sites providing global exposure and professional network expansion
Comprehensive technical development program to become a drug product technical expert in parenteral manufacturing
Cross-functional collaboration with global operations teams and contract manufacturing partners enhancing career versatility
Direct involvement in new product introductions and commercial production phases offering diverse project exposure
Professional development through hands-on experience with cutting-edge biopharmaceutical manufacturing technologies

Key Responsibilities

Lead technical troubleshooting and provide expert solutions for complex parenteral drug product manufacturing challenges across multiple processing stages including drug substance thawing, formulation, filling, lyophilisation, and inspection
Drive strategic partnerships with contract manufacturing SMEs and global operations teams to ensure seamless technology transfer and operational excellence
Spearhead cross-site team initiatives to proactively identify and resolve manufacturing issues, directly impacting product quality and commercial success
Deliver specialized process development expertise in critical areas including aseptic processing, process characterization, technology transfer, and process validation to support commercial operations
Execute comprehensive technical evaluations of non-conformances and corrective actions, ensuring regulatory compliance and operational efficiency
Establish and maintain strategic relationships with contract manufacturing partners through site visits and collaborative problem-solving

Requirements

Education

Bachelor's degree in Science, Engineering or relevant quality discipline

Experience

3-5 years pharmaceutical manufacturing experience in drug product or drug substance manufacturing environment

Required Skills

Knowledge of cGMP's Proven problem-solving ability Excellent oral and written communications skills Experience with aseptic drug product processes Experience with different aseptic drug product presentations Experience with quality testing methods for biological molecules Aseptic drug product validation experience Experience dealing with contract manufacturing organisations Project management experience Demonstrated ability to lead and take responsibility

Certifications

Full clean driving licence required
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Sauge AI Market Intelligence

Industry Trends

The biopharmaceutical industry is experiencing unprecedented growth in biologics and novel therapeutic modalities, with monoclonal antibodies and advanced protein therapeutics driving significant demand for specialized manufacturing expertise. This trend is creating substantial opportunities for process development engineers who can navigate complex aseptic manufacturing requirements. Contract manufacturing organizations (CMOs) are becoming increasingly critical to pharmaceutical supply chains, with companies like Amgen expanding their reliance on external manufacturing partners to improve flexibility and reduce capital investment. This shift is creating high demand for engineers who can effectively manage and optimize these partnerships. Regulatory agencies are intensifying their focus on manufacturing process validation and quality systems, particularly for sterile drug products. This regulatory environment is driving demand for professionals with deep expertise in process characterization, validation, and cGMP compliance. The trend toward personalized medicine and smaller batch sizes is requiring more sophisticated manufacturing approaches, particularly in fill-finish operations for various drug product presentations including pre-filled syringes and cartridges.

Role Significance

Typically operates within a team of 8-12 process development professionals, with matrix reporting relationships to global operations, quality assurance, and contract manufacturing teams. The role involves leading project teams of 4-6 members during specific assignments and technology transfer activities.
This is a mid-level technical role with significant autonomous decision-making authority and leadership responsibilities. The position requires independent problem-solving capabilities and the ability to influence cross-functional teams and external partners, indicating substantial professional responsibility within Amgen's global manufacturing network.

Key Projects

New product introduction campaigns involving technology transfer to contract manufacturing sites Commercial manufacturing optimization projects focused on yield improvement and cost reduction Process validation and characterization studies for regulatory submissions Cross-site harmonization initiatives to standardize manufacturing processes across multiple contract partners Equipment qualification and facility commissioning projects at new manufacturing sites

Success Factors

Deep technical expertise in aseptic processing and sterile manufacturing operations, combined with the ability to translate complex technical concepts into actionable solutions for diverse stakeholders including contract manufacturers and regulatory agencies. Strong relationship management and communication skills to effectively collaborate with external partners and internal cross-functional teams across different cultures and time zones, particularly given the European focus of the role. Proven ability to work independently and make critical decisions under pressure, especially during manufacturing investigations and troubleshooting scenarios that directly impact product supply and patient access. Comprehensive understanding of pharmaceutical quality systems and regulatory requirements, with the ability to navigate complex cGMP environments and support regulatory submissions and inspections.

Market Demand

High demand driven by the expanding biologics market, increased outsourcing to contract manufacturers, and the specialized nature of aseptic processing expertise. The combination of technical complexity and regulatory requirements creates a talent shortage for qualified process development engineers.

Important Skills

Critical Skills

cGMP knowledge and regulatory compliance expertise are absolutely essential as this role involves direct oversight of manufacturing operations that must meet strict regulatory standards. Any deficiencies in this area could result in regulatory violations, product recalls, or manufacturing shutdowns. Aseptic processing expertise is fundamental to success in this role, as the majority of responsibilities involve sterile drug product manufacturing. This specialized knowledge is difficult to acquire and highly valued in the industry, making it a key differentiator for career advancement. Problem-solving and troubleshooting abilities are critical given the complex nature of biopharmaceutical manufacturing and the potential for significant business impact from manufacturing issues. The ability to quickly identify root causes and implement effective solutions directly affects product quality and supply reliability.

Beneficial Skills

Language skills in Italian or German would provide significant advantages for communication with European contract manufacturing partners and could accelerate career progression within Amgen's European operations network. Advanced degrees in science or engineering demonstrate deeper technical knowledge and research capabilities that are increasingly valuable as manufacturing processes become more sophisticated and data-driven. Project management certification and experience would enhance effectiveness in leading cross-functional teams and managing complex technology transfer projects, skills that are essential for progression to senior management roles.

Unique Aspects

This role offers exceptional exposure to Amgen's global contract manufacturing network, providing unique insights into how leading biotechnology companies manage complex supply chains and manufacturing partnerships across multiple countries and regulatory jurisdictions.
The position involves working with diverse therapeutic modalities including monoclonal antibodies, therapeutic proteins, and novel drug formats, offering broader technical exposure than typical manufacturing roles focused on single product categories.
The requirement for European travel and direct collaboration with contract manufacturing partners provides valuable international experience and relationship-building opportunities that are highly valued in the pharmaceutical industry.
The role combines technical depth in aseptic processing with business impact through direct involvement in commercial manufacturing and new product launches, offering a unique blend of technical and commercial expertise development.

Career Growth

Progression to senior technical roles typically occurs within 3-5 years, with management opportunities available within 5-7 years for high-performing individuals who demonstrate strong leadership capabilities and business acumen.

Potential Next Roles

Senior Process Development Engineer with expanded technical leadership responsibilities Manufacturing Sciences Manager overseeing multiple product lines and manufacturing sites Contract Manufacturing Director managing strategic partnerships and vendor relationships Technical Operations Manager with P&L responsibility for manufacturing operations Regulatory Affairs Manager specializing in manufacturing and quality compliance

Company Overview

Amgen

Amgen is a leading global biotechnology company and one of the world's largest independent biotech firms, with a robust pipeline of innovative medicines and a strong focus on serious illnesses. The company has established significant manufacturing capabilities worldwide and maintains a strong presence in Ireland as part of its European operations strategy.

Amgen holds a dominant position in the biotechnology sector with multiple blockbuster drugs and a strong pipeline of innovative therapies. The company's focus on biologics and novel therapeutic modalities positions it at the forefront of industry trends, making it an attractive employer for pharmaceutical professionals seeking exposure to cutting-edge technologies.
The Dún Laoghaire facility represents Amgen's strategic commitment to European operations, serving as a key hub for supporting contract manufacturing activities across the region. This location provides employees with exposure to Amgen's global manufacturing network while benefiting from Ireland's favorable business environment and skilled workforce.
Amgen is known for its science-driven culture that emphasizes innovation, collaboration, and patient focus. The company typically offers comprehensive professional development opportunities, competitive compensation packages, and a collaborative work environment that encourages scientific excellence and cross-functional teamwork.
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