Ascend PM are hiring a Process Development Engineer to join our clients expanding team, a multinational biopharmaceutical company based in Dublin. Initially 12 Month Contract with view to extend. Contact or email CV to [email protected] for more information.
Overview:
The successful candidate will provide Process Development support for syringe filling and Single use technologies development for drug product Formulation & Filling processes.
The candidate will provide technical support to large molecule and small molecule drug product manufacturing as well as part of the global Process Development (PD) organization.
Key Responsibilities:
• Developing single use systems in collaboration with site teams and network for DP formulation and filling.
• Authoring / verification of single use qualification packages.
• Filling characterisation support (Filling recipe development - protocol development / execution and reporting.)
• 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.
• 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.
Experience & Qualifications:
• A third level Bachelor’s Degree in Science, Engineering or a relevant Quality discipline
• 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.