Process Development Engineer

Career Category

Job Description

This role will be based out of Amgen Dun Laoghaire, as part of the global Process Development

organization. This role will require the candidate to 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.

Depending on assignments, 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. International travel will be required to visit contract manufacturing partner sites in Europe.

The successful candidate will:

• Develop as a drug product technical expert, to provide leadership and solutions 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 commercial phases.
• Work with contract manufacturing partner SME’s, Global Operations, Contract Manufacturing Quality and drug product process teams.
• Work as a member of cross site teams to support contract manufacturers and to identify and resolve potential issues
• Provide process development expertise for commercial drug product processing in specific areas such as aseptic processing, process characterisation, technology transfer, and process validation.
• Troubleshoot issues with drug product processing technologies and equipment.
• Identify and implement operational improvements for current and new sterile operations.
• Support commercial drug product manufacturing operations and contract manufacturing quality with technical evaluation of NC/CAPA.
• Visit contract manufacturing sites to observe production operations and build relationships

Basic Qualifications:

• 3 -5 years' pharmaceutical manufacturing experience in either a drug product or drug substance manufacturing environment
• Knowledge of cGMP’s
• Proven problem-solving ability
• Excellent oral and written communications skills
• Strong academic results in a third level bachelor’s degree in Science, Engineering or a relevant quality discipline
• Full clean driving licence required to facilitate travel

Preferred Qualifications and Experience:

• Language skills such as Italian or German.
• Masters or PhD in a Science or Engineering or related discipline
• Experience with aseptic drug product processes such as; component preparation (siliconization, autoclaving, depyrogenation), sterile filtration, filter integrity testing, filling, freeze drying, capping, manual and automated visual inspection
• Experience with different aseptic drug product presentations such as pre-filled syringes, cartridges, lyophilised vials and liquid vials
• Experience with the quality testing methods and interpretation of results for biological molecules
• Aseptic drug product validation experience such as; media fill, sterilisation validation, equipment qualification, process validation
• Experience dealing with contract manufacturing organisations
• Project management experience
• Demonstrated ability to lead and take responsibility.