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Process Development - Sr. Associate Tech Engineering - Job Opportunity at Amgen

Dún Laoghaire, Ireland
Full-time
Mid-level
Posted: July 23, 2025
On-site
EUR 55,000 - 70,000 per year, considering this is a mid-level position in Ireland's growing biotechnology sector, with Amgen's competitive compensation structure and the specialized nature of biologics manufacturing expertise required

Benefits

Comprehensive pharmaceutical industry benefits package typical of multinational biotechnology companies, providing competitive healthcare coverage and professional development opportunities
Access to cutting-edge biotechnology research and development environment, offering exposure to innovative drug development processes and advanced analytical tools
Career advancement opportunities within a global pharmaceutical network, enabling cross-functional collaboration and international project exposure

Key Responsibilities

Lead statistical trend analysis and investigations for critical in-process manufacturing data, directly impacting product quality and regulatory compliance across multiple biological drug products
Drive monthly data reporting initiatives to network product leads, establishing data-driven decision making frameworks that influence manufacturing strategy and process optimization
Collaborate with cross-functional teams to resolve complex manufacturing investigations and CAPA closures, contributing to continuous improvement initiatives that enhance operational efficiency
Execute and maintain automated trend analysis systems supporting product reviews, ensuring regulatory compliance and facilitating faster time-to-market for biological drug products
Manage database mapping and automated reporting capabilities for vial and syringe drug products, maintaining critical infrastructure that supports manufacturing operations
Configure and maintain validated Spotfire reports for ongoing compliance requirements, ensuring accurate regulatory reporting and audit readiness
Calculate and document statistical control limits for manufacturing processes, establishing quality parameters that guide production decisions
Deliver comprehensive process monitoring summaries for Annual Product Reviews, providing critical data analysis that supports regulatory submissions
Draft and update site process monitoring plans and SOPs, contributing to standardization and knowledge management across the organization

Requirements

Education

Bachelors or Masters degree in Science, Engineering, data science or data analytics

Experience

2+ years experience in manufacturing environment (biotechnology, pharmaceutical, medical device or high volume manufacturing) using process data and statistical analysis to drive decision making

Required Skills

Statistical analysis tools (JMP, Minitab, SAS, R) Visual analysis tools (Spotfire, Cognos, SAP BO, Tableau) SPC trending, Nelson/WACO trend rules, process capability SQL for creating custom queries from databases Accessing data from manufacturing systems (Werum PAS-X, PI, SM LIMS) Biological drug product manufacturing and Inspection processes Vial and syringe filling production lines operation and automation

Certifications

Lean 6-Sigma training
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Industry Trends

The biotechnology and pharmaceutical industry is experiencing unprecedented growth in biologics manufacturing, with companies increasingly investing in advanced process analytical technology (PAT) and real-time monitoring systems to ensure product quality and regulatory compliance. This trend is driving demand for professionals who can bridge the gap between engineering, data science, and regulatory affairs. Digital transformation in pharmaceutical manufacturing is accelerating the adoption of Industry 4.0 technologies, including advanced data analytics, machine learning, and automated reporting systems. Companies are seeking professionals who can implement and maintain these sophisticated systems while ensuring GMP compliance. Regulatory agencies worldwide are placing greater emphasis on continuous process verification and real-time release testing, creating increased demand for process development engineers with strong statistical analysis capabilities and experience in trend monitoring systems.

Role Significance

Typically works within a team of 6-12 process development professionals, reporting to a team lead and collaborating closely with quality assurance, manufacturing operations, and regulatory affairs teams across the organization
This mid-level position represents a crucial bridge between technical execution and strategic process development, with significant responsibility for maintaining critical manufacturing data systems and supporting regulatory compliance across multiple product lines. The role demonstrates clear progression from associate-level work while building toward senior technical leadership.

Key Projects

Implementation and validation of automated process monitoring systems for new biological drug products Statistical analysis and trending projects supporting regulatory submissions and annual product reviews Cross-functional investigations into manufacturing deviations and process improvements Development and maintenance of control strategies for critical process parameters in biologics manufacturing

Success Factors

Deep understanding of statistical process control methodologies and their application in biologics manufacturing, as regulatory compliance and product quality depend heavily on robust statistical analysis and trend detection capabilities. Proficiency in advanced data visualization and analysis tools, particularly Spotfire and SQL, as these platforms are critical for creating automated reporting systems and extracting insights from complex manufacturing datasets. Strong collaborative skills and ability to work effectively with cross-functional teams, as process development requires close coordination with quality assurance, regulatory affairs, and manufacturing operations to ensure successful project outcomes. Attention to detail and commitment to GMP compliance, as any errors in data analysis or reporting could have significant regulatory and commercial implications for biological drug products.

Market Demand

High demand driven by Ireland's position as a major hub for pharmaceutical and biotechnology manufacturing, combined with the specialized skill set required for biologics process development and the ongoing expansion of biotech manufacturing facilities in the Dublin region

Important Skills

Critical Skills

Statistical analysis proficiency using tools like JMP, Minitab, SAS, or R is absolutely essential as this role requires daily application of statistical process control methodologies, trend analysis, and capability studies that directly impact product quality and regulatory compliance. These skills form the foundation for all data-driven decision making in the position. Experience with visual analysis tools, particularly Spotfire, is critical because the role requires creating and maintaining automated reporting systems that support regulatory submissions and ongoing compliance monitoring. The ability to configure and validate these systems is essential for operational success. Understanding of GMP requirements and regulatory compliance is crucial as all work must meet strict pharmaceutical manufacturing standards, and any compliance failures could result in regulatory action, product recalls, or significant financial impact to the organization.

Beneficial Skills

Lean Six Sigma certification and continuous improvement methodologies would significantly enhance effectiveness in identifying process optimization opportunities and leading cross-functional improvement initiatives. Advanced SQL and database management skills would enable more sophisticated data analysis and custom reporting capabilities, increasing value-add to the organization and supporting career advancement. Knowledge of machine learning and advanced analytics techniques would position the candidate for future roles in digital transformation initiatives and next-generation process monitoring systems.

Unique Aspects

This role offers direct exposure to cutting-edge biologics manufacturing processes, including specialized vial and syringe filling operations that represent some of the most technically challenging aspects of pharmaceutical manufacturing.
The position provides opportunity to work with advanced process analytical technology and automated monitoring systems that are at the forefront of Industry 4.0 implementation in pharmaceutical manufacturing.
The role combines technical engineering expertise with statistical analysis and regulatory compliance, offering a unique skill development opportunity that is highly valued in the biotechnology industry.
Working within Amgen's global network provides exposure to international regulatory requirements and best practices, enhancing career development potential for future leadership roles.

Career Growth

Typical progression to senior level within 3-5 years, with potential for team leadership roles within 5-7 years, depending on performance and additional qualifications in areas such as advanced statistics or regulatory affairs

Potential Next Roles

Senior Process Development Engineer with expanded responsibility for process design and optimization Process Monitoring Team Lead with management responsibilities for data analytics initiatives Principal Scientist role focusing on advanced process analytical technology implementation Regulatory Affairs specialist with expertise in process validation and statistical analysis

Company Overview

Amgen

Amgen is one of the world's largest independent biotechnology companies, pioneering the development of innovative medicines based on advances in cellular and molecular biology. Founded in 1980, the company has established itself as a leader in biologics development and manufacturing, with a focus on serious illnesses including cancer, kidney disease, and inflammatory conditions.

Amgen holds a dominant position in the global biotechnology market with annual revenues exceeding $25 billion, ranking among the top biotechnology companies worldwide. The company's strong pipeline of innovative therapies and established manufacturing capabilities position it as a market leader in biologics development.
The Dublin location represents Amgen's significant European manufacturing and development operations, with Ireland serving as a key hub for the company's global supply chain and regulatory strategy for European markets. This facility plays a crucial role in supporting Amgen's international expansion and market access initiatives.
Amgen maintains a science-driven culture that emphasizes innovation, collaboration, and commitment to improving patient outcomes. The company is known for investing heavily in employee development and maintaining high standards for scientific excellence and regulatory compliance.
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