Job Description
PE Global is currently recruiting for a Process Engineer for a leading multi-national Biologics client based in Carlow. This is a shift role(24/7 e.g. 7am-7pm & or 7pm-7am) This is an initial 11-month contract position. Responsible for providing process, technical, and validation support to operations for commercial manufacturing and Process Simulation development and execution. Accountable for all studies associated with the development of new components, products, processes systems and facilities in relation to process simulations. Co-ordination, design and execution of commercial & Process simulations studies as required. Responsibilities Serve as technical support for manufacturing and new product introduction. Design/Author/Review/Approve/Execute process simulations studies in support of new product introduction and ongoing manufacturing support. Provide technical input into quality notification by authoring/reviewing/approving Process Simulation related investigations. Design/Author/Review/Approve/Execute commercial & process simulation qualification/validation documentation and studies in line with the standard approval process Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis Support continuous improvement through Lean Six Sigma methodologies. Leading and active participation in projects, system failure investigations and investigation reports, Execution/development of change controls to support the Process Simulation process Contribution to Kaizen events as appropriate. Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 whys etc.; Implement subsequent corrective action through the change management system. Serve as technical engineering representative for internal technical group discussions and represent technical operations Carlow at global technical forums in relation to process simulations. Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups. Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance. Requirements Bachelors Degree or higher preferred; ideally in a Science, Engineering or other technical discipline Experience in an Aseptic sterile manufacturing environment preferred Demonstrated ability to coach and lead change Strong Knowledge of Sterile Manufacturing Processes with a focus on delivery and results within highly regulated controlled environment 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*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: Process Engineer Manufacturing Biologics