Amgen
Scientific
SeniorEngineer
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Engineer at Amgen. Skills: parenteral drug product manufacturing, aseptic processing, process validation, protein drug product processing. remotely support manufacturing at various aseptic drug product contract manufacturing sites around Europe. support for new product introductions”
Industry & Context.
Proven problem-solving ability
Some International travel will be required to visit contract manufacturing partner sites in Europe, Visit contract manufacturing sites to support key production milestones and build relationships, Full clean driving license required to facilitate travel
What They're Looking For.
Must Have
Knowledge of cGMP’s and other worldwide regulatory requirements, Proven problem-solving ability, Excellent oral and written communications skills, A third level Bachelor’s degree in Science, Engineering or a relevant Quality discipline with 5 years' experience in a similar role OR Master’s degree & 3 years' directly related experience OR Associate’s degree & 10 years of directly related experience, Full clean driving license required to facilitate travel
Nice to Have
Language skills such as Italian or German would be an advantage, Masters or PhD in Science or Engineering, 5+ years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Process Validation, skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling, lyophilisation, and/or inspection processes, Knowledge of protein biochemistry with regard to chemical and physical stability, Project management skills including the ability to manage multiple projects and evaluate project resource requirements, knowledge of quality and regulatory systems, drug product manufacturing and process validation, Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion
What You'll Do.
remotely support manufacturing at various aseptic drug product contract manufacturing sites around Europe
support for new product introductions
ongoing commercial production
support a broad range of product formats (cartridges
freeze dried and liquid vials)
support a broad range of product types (including monoclonal antibodies
small molecules and more novel modalities)
Act as a drug product technical expert
to provide leadership and solutions when troubleshooting parenteral drug product manufacturing
for all processing stages from drug substance thawing
and transportation of vials
for parenteral products through the new product introduction (NPI) or post-NPI phases
Provide process development expertise for commercial drug product processing in specific areas such as aseptic processing
process characterization
and process validation
Troubleshoot issues with drug product processing technologies and equipment
Identify and implement operational opportunities for current and new sterile operations
Support commercial drug product manufacturing operations and external supplier quality with technical evaluation of NC/CAPA
How You'll Work.
Team & Collaboration
Build excellent business relationships with contract manufacturing partners, Global Operations, External Supplier Quality, and drug product process teams; Demonstrate the ability to lead, via cross-site teams, and in general by setting the agenda and identifying potential issues; Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion
Communication Scope
Excellent oral and written communications skills
Process & Methodology
Project management skills including the ability to manage multiple projects and evaluate project resource requirements
Full Job Description
## **Career Category** Scientific ## ## **Job Description** Reporting to the Senior Manager of External Process Engineering, this role will be based out of Amgen Dun Laoghaire, Co. Dublin as part of the global Process Development organization. This role will require the candidate to remotely support manufacturing at various aseptic drug product contract manufacturing sites around Europe. Assignments may include support for new product introductions, lifecycle changes and ongoing commercial production. The candidate may support a broad range of product formats (cartridges, syringes, freeze dried and liquid vials); and a broad range of product types (including monoclonal antibodies, therapeutic proteins, small molecules and more novel modalities), across multiple manufacturing sites. Some International travel will be required to visit contract manufacturing partner sites in Europe. The successful candidate will: * Act as a drug product technical expert, to provide leadership and solutions when troubleshooting parenteral drug product manufacturing, for all processing stages from drug substance thawing, formulation, filling, lyophilisation, inspection, and transportation of vials, syringes and devices, for parenteral products through the new product introduction (NPI) or post-NPI phases. * Build excellent business relationships with contract manufacturing partners, Global Operations, External Supplier Quality, and drug product process teams. * Demonstrate the ability to lead, via cross-site teams, and in general by setting the agenda and identifying potential issues * Provide process development expertise for commercial drug product processing in specific areas such as aseptic processing, process characterization, technology transfer, and process validation. * Troubleshoot issues with drug product processing technologies and equipment. * Identify and implement operational opportunities for current and new sterile operations. * Support commercial drug product manufacturi
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