Senior Process Development Engineer – Sterile Filling

Biopharma Careers; Dún Laoghaire; On-site; EUR 70,000 - 95,000; Full time

Job summary

Amgen Dun Laoghaire is seeking a Senior Engineer, Process Development to provide technical leadership for syringe filling lines and support site expansion. The role involves process characterization, qualification of filling technologies, and implementation of SUS for two new lines.

You will partner with Manufacturing, Engineering, Quality, Regulatory Affairs, and external vendors to deliver robust, compliant manufacturing solutions. Strong background in sterile processing and cGMP is required.

Qualifications

• Bachelor's degree in Science or Engineering and 7+ years of related experience; or Master’s 5+ years; or Associate’s 12+ years.
• Knowledge of cGMP and global regulatory requirements.
• Strong understanding of aseptic manufacturing technologies and cGMP expectations.
• Ability to apply engineering and scientific principles to filling process design and implementation.
• Demonstrated problem-solving and communication skills.
• Ability to work effectively in cross-functional teams in a regulated environment.

Responsibilities

• Lead filling process characterization activities, including recipe development, protocol design, execution, analysis, and reporting.
• Provide technical leadership for qualification and lifecycle management of filling technologies and SUS.
• Support technology transfer, validation, and commercial manufacturing with scientific evaluations.
• Troubleshoot process, equipment, and product issues using data-driven methods and implement CAPA.
• Lead investigations, risk assessments, and deviation management across drug product operations.
• Collaborate with global SMEs to leverage best practices and network harmonization.

Skills

Technical leadership

Cross-functional collaboration

Problem-solving

Effective communication

Stakeholder management

Education

Bachelor's degree in Science or Engineering

Master's degree (preferred)

PhD (preferred)

Job description

Amgen Dun Laoghaire is seeking a Senior Engineer, Process Development to provide technical leadership for syringe filling lines and support site expansion. The role involves process characterization, qualification of filling technologies, and implementation of SUS for two new lines.

You will partner with Manufacturing, Engineering, Quality, Regulatory Affairs, and external vendors to deliver robust, compliant manufacturing solutions. Strong background in sterile processing and cGMP is required.