We’re currently recruiting for an exciting opportunity with a Bioharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Development of characterisation studies, engineering runs, electronic batch record creation, validation plans, process performance qualifications for syringe filling.
• Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
• Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards) with a full understanding of CMC business process related to technology transfer.
• Participate in process validation cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organizational goals and project milestones.
• Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
• Actively communicates across functions and sites and is a strong collaborator with all the functional groups at the receiving site, sending site and corporate functions.
• Act as the responsible point contact from site for the transfer project for drug product teams and Global Operations Teams.
• Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations and input to site validation guidance documents.
• Collate and report on relevant shipping and filter validation.
• Assist in deviation and exception resolution and root cause analysis.
• Contribute to product quality assessments and process flow documents.

• Third level Bachelor’s degree in science, engineering or equivalent discipline with 5 years experience in a commercial manufacturing or NPI role, advanced qualifications are beneficial
• 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 protein freeze-thawing, filtration, mixing, filling (PpK / batch homogeneity). 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.