Job Description
A Process Engineer P2 is required on an initial 11-Month contract basis by CareerWise Recruitment for our Carlow-based multinational bio-pharmaceutical client. Hybrid Day role with expectation to support shift intermittently when Floor activities/studies are ongoing. The successful candidate 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 above site groups. You will typically have prior related work experience; ideally in manufacturing, preferably GMP Setting but will consider applicants from other working environments as long as they have technology transfer experience. Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity for this role. THE ROLE: 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 Demonstratable experience of leading technical related projects Evidence of continuous professional development is desirable. Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity. Knowledge of regulatory/code 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. Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner Please call Aisling OHagan-Yil today for further information on or email: CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. Skills: GMP Pharma QMS