Lead Process Development Engineer – NPI & Tech Transfer

Amgen SA; Ireland; Remote; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Competitive 401k-like plan

Job summary

Amgen in Ireland seeks a Process Development professional to support NPIs, technology transfer, and lifecycle changes for parenteral products. You will provide SME input for formulation, filling and QC characterization and support large and small molecule drug product manufacturing within the global PD organization.

The role includes development of validation plans, PPQs and CAPA execution, with liaison to operations, engineering and external vendors to ensure robust, compliant processes for

Qualifications

• Bachelor's degree in Science, Engineering or related quality discipline with 5 years' experience OR Master's degree with 3 years of related experience.
• Knowledge of cGMPs and worldwide regulatory requirements.
• Strong problem solving and communication skills.

Responsibilities

• Leads NPIs and lifecycle changes from a PD perspective and supports technology transfer.
• Contributes to regulatory filings and responds to regulator questions as needed.
• Provides SME support for sterile processing, filling, and validation activities.
• Develops and characterizes drug product processes and supports tech transfer to commercial sites.
• Leads risk assessments, CAPA, and cross-site project activities.

Skills

Process development

Tech transfer

NPI support

Regulatory filings

Sterile processing

Problem solving

Education

Bachelor's degree in Science/Engineering

Master's degree in Science/Engineering

Associate's degree with experience

Job description

Amgen in Ireland seeks a Process Development professional to support NPIs, technology transfer, and lifecycle changes for parenteral products. You will provide SME input for formulation, filling and QC characterization and support large and small molecule drug product manufacturing within the global PD organization.

The role includes development of validation plans, PPQs and CAPA execution, with liaison to operations, engineering and external vendors to ensure robust, compliant processes for