Senior Engineer

Amgen; Ireland; On-site; EUR 90,000 - 130,000; Full time

Job summary

Amgen Dun Laoghaire, Co. Dublin, Ireland, is seeking a Senior Manager-equivalent role within External Process Engineering.

The position is based in Dun Laoghaire and will remotely support manufacturing at European aseptic contract sites. The role involves leading cross-site teams, providing process development expertise for commercial drug product processing, and partnering with contract manufacturers to ensure quality and regulatory compliance.

Qualifications

• Knowledge of cGMPs and worldwide regulatory requirements.
• Proven problem-solving ability.
• Excellent oral and written communications skills.
• Bachelor's/Master's/Associate degree + experience as specified in the basic qualifications.
• Full clean driving license required to facilitate travel.

Responsibilities

• Act as a drug product technical expert, to provide leadership and solutions for parenteral drug product manufacturing from thawing to transport.
• Build relationships with contract manufacturing partners and internal teams.
• Lead cross-site teams and set agendas to identify issues.
• Provide process development expertise for commercial drug product processing (aseptic processing, transfer, validation).
• Troubleshoot drug product processing technologies and equipment.
• Identify and implement opportunities for current and new sterile operations.
• Support commercial manufacturing and supplier quality with NC/CAPA evaluations.
• Visit CM sites to support milestones and build relationships.

Skills

Problem-solving

Communication

Leadership

Travel readiness

Education

Bachelor's degree in Science, Engineering or related field

Master's degree in Science or Engineering

Associate's degree with 10 years of related experience

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 manufacturing operations and external supplier quality with technical evaluation of NC/CAPA.
• Visit contract manufacturing sites to support key production milestones and build relationships.

Basic Qualifications:

• 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.

Preferred Qualifications and Experience:

• 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.
• Strong 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.
• Strong 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.