Senior Engineer

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

Job summary

Amgen Dun Laoghaire, Co. Dublin, Ireland, is seeking a senior Process Development professional to lead parenteral drug product processing activities within the global organization.

The role involves support for NPIs, lifecycle changes, and a broad range of product formats across multiple manufacturing sites. The successful candidate will build strong relationships with CM partners, Global Operations, and External Supplier Quality, and may travel to CM sites in Europe.

Qualifications

• Knowledge of cGMPs and regulatory requirements.
• Proven problem-solving ability and strong communication skills.
• Bachelor’s degree in Science/Engineering with 5 years’ experience OR Master’s with 3 years’ experience OR Associate’s with 10 years’ experience.

Responsibilities

• Act as drug product technical lead to troubleshoot parenteral manufacturing across processing stages.
• Build relationships with contract manufacturing partners and cross-functional teams.
• Lead cross-site teams and set agendas to identify issues.
• Provide process development expertise for commercial drug product processing including aseptic processing, transfer, and validation.
• Troubleshoot issues with drug product processing technologies and equipment.
• Identify and implement opportunities for improvement in sterile operations.
• Support commercial manufacturing operations and external supplier quality with NC/CAPA evaluations.
• Visit contract manufacturing sites to support milestones and build relationships.

Skills

cGMP knowledge

Problem-solving

Communication skills

Driving license

Education

Bachelor's degree in Science/Engineering

Master's degree in Science/Engineering

Associate's degree

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 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.

Salary Range

70,408.90EUR-95,259.10EUR