Process Engineer required as part of NPI process team with out multinational biotech company based in South Dublin. As part ot the process team you will provide process development support to the new product introduction (NPI) changes. You will be exclusively be involved in the execution of process performance qualification (PPQ) specifically documentation oversight and contribution to filings required for regulatory submission. The position will report to Process Development Principle Engineer.
As Process Engineer you will:
o Be part of the team accountable for success of the product transfer project for process performance qualification and ultimately to regulatory approval of the new product.
o Be a contributor to regulatory filings as part of the NPI process throughout the authoring, editing and submission process but also be available for response to regulator questions as and when required.
o Ensuring all aspects of activity adheres to required policies and procedures, including safety and training.
o Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards) with a full understanding of the CMC business process related to technology transfer.
o Participate in 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.
o Actively communicates across functions and sites and is a strong collaborator with all the functional groups.
As Process Engineer you will have:
o 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.
o Knowledge of cGMPs and other worldwide regulatory requirements.
o Problem solving ability and excellent oral and written communications skills.
o 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.
o Strong skills in applying fundamental engineering and scientific principles to the implementation and process validation of protein freeze-thawing, filtration, mixing, filling (PpK / batch homogeneity) and/or lyophilisation processes. Knowledge of protein biochemistry with regard to chemical and physical stability.
Please contact Kathy on 021 4777329 email@example.com for full details on this role or apply directly through this advert.