The Senior Engineer, Process Development will provide technical leadership and process development support for the Optima syringe filling lines at Amgen Dun Laoghaire (ADL). The successful candidate will play a key role in supporting major site expansion initiatives, including filling process characterization, qualification of filling technologies, and implementation of new single-use technologies for two new syringe filling lines.As part of the Process Development organization, the Senior Engineer will provide scientific and engineering support for large molecule and small molecule drug product manufacturing. The role requires a strong combination of technical expertise, leadership, communication, and stakeholder management skills to support the successful delivery of strategic site and network objectives.
The successful candidate will act as a technical leader within cross-functional teams, translating complex technical concepts into clear, data-driven recommendations for manufacturing operations, project teams, senior leadership, and external partners. They will be expected to influence decision-making, facilitate technical alignment, and drive resolution of complex process and operational challenges while maintaining a strong focus on safety, quality, compliance, and operational excellence.
Leadership emphasis: This role requires the ability to lead technical discussions, communicate complex topics clearly, influence without authority, and support cross-functional decision-making across site, network, and external partner teams.
Key Responsibilities
Technical Leadership & Process Development
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Lead and support filling process characterization activities, including recipe development, protocol design, execution, statistical analysis, interpretation of results, and technical reporting.
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Apply process development expertise to sterile drug product manufacturing, including aseptic processing, filling operations, process characterization, and single-use technologies (SUS).
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Provide technical leadership for the qualification, implementation, and lifecycle management of filling technologies and manufacturing systems.
- Support technology transfer, process validation, and commercial manufacturing activities through scientific and engineering evaluations.
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Troubleshoot manufacturing process, equipment, and product performance issues using structured, data-driven methodologies to identify root causes and implement sustainable corrective actions.
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Lead or support investigations, deviation management, risk assessments, CAPA development, and implementation activities across drug product operations.
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Contribute to validation strategies, process understanding, product quality assessments, and continuous improvement initiatives.
Cross-Functional Collaboration & Stakeholder Engagement
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Lead and influence cross-functional teams to achieve project milestones and business objectives.
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Leads and participates in global cross-functional teams working effectively in a highly matrixed team environment to influence and drive change, efficiency, and foster strong relationships.
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Partner closely with Manufacturing, Operations, Engineering, Quality, Validation, Supply Chain, Regulatory Affairs, and external vendors to deliver coordinated technical solutions.
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Build strong relationships across site and network organizations to drive alignment and facilitate effective knowledge sharing.
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Represent Process Development in project governance forums, technical reviews, operational readiness activities, and strategic planning discussions.
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Collaborate with global subject matter experts to leverage best practices and support network harmonization initiatives.
Technical Communication & Influence
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Communicate complex scientific and engineering concepts clearly and effectively to audiences with varying levels of technical expertise.
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Prepare and deliver technical presentations, executive summaries, business cases, and technical assessments to support key decision-making processes.
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Lead technical discussions, workshops, and cross-functional reviews to facilitate alignment on project priorities, risks, and mitigation strategies.
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Influence technical direction and project strategy through data-driven recommendations and sound scientific rationale.
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Communicate technical risks, project status, and mitigation plans effectively to senior management and project stakeholders.
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Support regulatory inspections, audits, and customer interactions through effective presentation and defense of technical information.
Leadership & Talent Development
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Serve as a technical mentor and coach to junior engineers and scientists, supporting capability development and knowledge transfer.
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Foster a culture of collaboration, scientific excellence, continuous improvement, and accountability.
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Demonstrate leadership beyond direct responsibilities by contributing to site initiatives, technical communities of practice, and organizational development activities.
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Promote effective communication and collaboration across diverse teams and stakeholder groups.
Compliance, Safety & Quality
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Ensure all activities comply with cGMP requirements, Amgen quality standards, and applicable global regulatory expectations, including FDA and EU regulations.
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Maintain an uncompromising commitment to safety, quality, compliance, and operational excellence.
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Review and approve technical documentation, protocols, reports, assessments, and quality system records as required.
Basic Qualifications
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Bachelor's degree in Science, Engineering, Quality or a related discipline and 7 years of directly related experience; OR Master's degree and 5 years of directly related experience; OR Associate's degree and 12 years of directly related experience.
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Knowledge of cGMP and applicable global regulatory requirements.
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Strong understanding of aseptic manufacturing technologies and cGMP expectations.
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Ability to apply engineering and scientific principles to formulation, single-use systems and filling process design and implementation.
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Demonstrated problem-solving skills with strong written, verbal and technical communication skills.
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Ability to work effectively in cross-functional teams in a highly regulated manufacturing environment.
Preferred Qualifications
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PhD or Master’s degree in Science or Engineering.
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5+ years of experience supporting commercial drug product manufacturing, sterile processing, process characterization, technology transfer, validation, or process development activities.
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Experience with drug product filling technologies, including peristaltic pump filling systems.
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Strong understanding of filtration, filling operations, process validation, and protein-based drug product manufacturing.
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Demonstrated expertise in quality systems, deviation investigations, CAPA development, and risk management.
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Proven ability to lead cross-functional teams and drive successful project delivery.
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Experience presenting technical information to leadership teams, governance forums, regulatory agencies, and external stakeholders.
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Demonstrated ability to influence stakeholders and drive alignment without direct authority.
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Strong technical writing skills, including preparation and review of protocols, reports, assessments, technical justifications, and executive communications.
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Excellent facilitation, stakeholder management, and interpersonal communication skills.
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Experience mentoring or developing engineers and scientists within a technical organization.
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Ability to communicate complex technical topics clearly, concisely, and effectively to both technical and non-technical audiences.
Leadership Profile
The successful candidate will be expected to demonstrate leadership beyond their immediate area of responsibility by influencing technical strategy, driving cross-functional initiatives, mentoring colleagues, and serving as a recognized subject matter expert in sterile drug product processing, filling technologies, and process development. The role requires strong communication, influencing, and stakeholder engagement skills to effectively support site expansion activities and future business growth.
