Job Description
Elusav Recruitment have an excellent opportunity with a leading global Pharma and Biopharma company who is seeking a Process Engineer to bring value to their site in Carlow, Ireland. The Process Engineerwill lead/execute production floor-based activities, will participate on a team of engineers, will plan and execute C&Q, validation activities as required, as well as design and develop engineering studies. Responsibilities: 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. Execution of equipment/qualification validation programs; including re-qualification and re-validation. 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 the company 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. Prior related work experience; ideally in manufacturing, preferably GMP Setting. Typically have 3 years related work experience in Aseptic manufacturing / process engineering. Knowledge of regulatory/core requirements to Irish, European and International Codes, Standards and Practices. Report, standards, policy writing skills required. Equipment and process validation. Sterile filling processes and equipment. Proficiency in Microsoft Office and job-related computer applications required. Lean Six Sigma Methodology experience desired. Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner. Contact: If you would like to learn more about the vacancy, apply now, or contact Stephen O'Brien on or . Skills: GMP Validation Documentation