Manufacturing Engineer Opportunity
We are seeking a highly skilled Manufacturing Engineer to join our team in Dublin, Ireland for a 6-month contract. This is an exciting project that offers the opportunity to learn new technology and develop current skills within a fast-paced environment.
Responsibilities:
* Contribute to cross-functional teams (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 manufacturing.
* Support product changeover protocols to allow a smooth transition from sustaining to new product manufacturing.
* Represent Manufacturing at meetings to ensure the end-user requirements are represented.
* Support process technology transfer and the preparation of manufacturing documentation for development, engineering, and PPQ batches.
* Work with the sustaining team to understand current issues and ensure the impact of new products is defined, agreed, and understood.
* Write process impact assessments to support new product introduction.
* Provide 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.
* Support the disposition process when required.
* Own & drive change controls, CAPAs, 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 documentation and provide technical training and knowledge transfer to the Operations team.
Key Requirements:
* Ability to demonstrate proficiency in communicating and collaborating at various levels, coupled with excellent organization and planning skills.
* Proven success working in a team environment, strong leadership & influencing skills, and 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 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.