Sr. Engineer Process Development

/ verification of single use qualification packages.

• Filling characterisation support (Filling recipe development - protocol development / execution and reporting.)

• Demonstrated ability in providing leadership to multi-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.

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

• Provide process development expertise for drug product processing in specific areas such as sterile processing, process characterization, filling, SUS. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all 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 root cause.

• Lead or assist in deviation / exception resolution and root cause analysis.

• Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.

• Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards).

• Review and post-approve process validation protocols and assessments from a quality system documentation perspective.

• Contribute to product quality assessments and process flow documents.

• Liaise with Operations, Engineering and external vendors regarding new or amended equipment which would impact the validated process.

Basic Qualifications:

• 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 of directly related experience OR Associate's degree & 10 years of directly related experience.

• Knowledge of cGMPs and other worldwide regulatory requirements.

• Thorough knowledge of aseptic manufacturing technologies and cGMP.

• Problem solving ability and excellent oral and written communications skills

• Strong skills in applying fundamental engineering and scientific principles to the design and implementation of Formulation Single use systems and Filling.

Preferred Qualifications:

• PhD or Masters in Science or Engineering.

• 10 + 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, implementation and process validation of formulation, mixing, filtration and filling. Knowledge of protein biochemistry regarding chemical and physical stability

• Background in Drug product Filling technologies, Peristaltic pumping / Time pressure filling.

• 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 skill is essential for this role.

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