PROCESS ENGINEER

Process Engineer - Tech Transfer/NPI - Carlow/Hybrid 2-3 days on site - 11-Months  With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Process Engineer to join their team to support multiple capital projects taking place onsite in Carlow.
This is a fantastic opportunity to work on a state-of-the art fill-finish facility and the company’s first stand-alone vaccine and biologics plant outside the US.
Role Summary.
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.
Skills and Knowledge.
Bachelor’s 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  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  If you are interested, please apply now for immediate consideration and further information.
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