Career Category

Job Description

Job Posting Title              Sr Engineer Process Development - FTC

Career Category               Process Development

Employee Subgroup        FTC

Country (State/Region) Ireland

Location (City)   Ireland - ADL

Amgen Job Description:

The Sr Engineer provides process development technical support to large molecule and small molecule drug product manufacturing at ADL as well as being part of the global Process Development organization. The input provided will include support of process performance and implementation of process improvement strategies:

• Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting issues in drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation, for parenteral products.

• Provides process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characterization, Tech Transfer and Validation. Supports commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Adopts a customer-centric interface with manufacturing, and all partner support functions, to provide robust and coordinated support to manufacturing.

• Troubleshoots issues with drug product processing technologies and equipment. Champions use of data-driven analyses and visualizations. Investigates to determine true root cause.

• Develops and characterizes drug product processes and transfer technology to commercial drug product sites.

• Conducts risk assessment for drug product operations and propose / implement appropriate CAPA.

• Identifies and implements operational opportunities for current and new sterile operations.

• Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management. Be a link to manufacturing on key investigations as a process expert.

Basic Qualifications        

• Doctorate & 2 years of directly related experience Or

• Master’s degree & 5 years of directly related experience Or

• Bachelor’s degree & 8 years of directly related experience Or

• Associate’s degree & 12 years of directly related experience

Preferred Qualifications

• Masters in Science or Chemical Engineering, or related discipline

• 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 Validation.

• Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization 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 systems, Drug Product Manufacturing and Validation.

• Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.

• Excellent Communication skills are essential for this role, as well as a demonstrated proficiency with the principles of Technical Writing.