Job Description
PE Global is currently recruiting for a Process Engineer for a leading multi-national Biologics client based in Carlow. This is an initial 11-month contract position. The Process Engineer will serve as technical support for new product introduction (NPI) and commercial manufacturing and will participate and/or lead cross functional or single function teams including liaising with vendors or site groups. Responsibilities Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process. Design/Author/Review/Approve/Execute Execution/development of change controls. Contribution to Kaizen events as appropriate Technical input into quality notification by authoring/reviewing/approving investigations Execution of equipment/qualification validation programs; including re-qualification and re-validation Support continuous improvement through Lean Six Sigma methodologies. Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues. Serve as technical engineering representative for internal technical group discussions and represent technical Operations Carlow at global technical forums. 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. Work collaboratively to drive a safe and compliant culture in Carlow. May be required to perform other duties as assigned. Requirements Bachelors Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline Min 3 years experience ideally in manufacturing, preferably GMP Setting Demonstrable experience of leading technical related projects 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 Tech Transfer Biologics