The Role PE Global are recruiting for a Manufacturing Engineer for our biopharmaceutical client based in Dublin 15. This is an initial 12 -month contract role. Job ResponsibilitiesContributes to cross functional team (Manufacturing, Engineering, QA, QC, Regulatory, Supply Chain, etc.) for process improvement implementations, new product start-ups or other process changes.Support new product introduction risk assessments to ensure the appropriate controls are in place to enable manufacturingSupport product change over protocols to allow a smooth transition from sustaining to new product manufacturingRepresent the Manufacturing at meeting to ensure the end user requirements are representedSupports process technology transfer, and the preparation of manufacturing documentation for development, engineering and PPQ batches.Identify process improvement projects for New Product Introduction and support projects to completion.Work with sustaining team to understanding current issues and ensure impact of new products are defined, agreed and understoodWrite process impact assessments to support new product introductionProvide SME input into cross-functional teams investigating & optimizing new manufacturing processes, procedures and documentation.Provide training to BPAs on new procedures.Support external and internal audits.Work with cross-functional teams on the introduction of consumables and raw materials to support New Product Introduction .Work to implement a "Right-First Time Culture" and provide leadership in the use of OE principles.Support the disposition process when requiredCarry out organizational activities such as purchasing & co-coordinating communication information.Own & drive change controls, CAPA's, investigations, improvement projects and operational safety.Minimize human error and work with operations to remove sources of error.Departmental Approver of operations procedures, electronic batch records and other GMP documentation and provide technical training and knowledge transfer to the Operations team.Support sustaining operations when required to ensure product supplyDevelop strong working relationships with Quality, Engineering, Technical Services, Supply Chain, Regulatory Affairs, Human Resources, Finance.Support and implement new technology solutions such as Single-Use technology.Educations & ExperienceAbility to demonstrate proficiency communicating and collaborating at a variety of levels, coupled with excellent organization and planning skills. In addition, must have proven success working in a team environment, as well as strong leadership & influencing skills, with flexibility to react to changing business needs. Problem solving and project management ability, as well as lean manufacturing experience is essential.Currently completing a Bachelors/Masters in Science, Engineering, or a related subject.In-depth theoretical knowledge of GMP biologics manufacturing equipment and process automation.Proven ability to support the closeout of complex technical investigations.Strong working knowledge of systems such as Delta V, MES Syncade and SAP.Excellent presentation skills.Interested candidates should submit an updated CV.Please click the link below to apply, or alternatively send an up-to-date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****