23583-Process Engineer-Carlow Contractor

Process Engineer – NPI

Purpose

The Process Engineer is responsible for introducing new processes and/or products (product transfer). The Process Engineer will develop and transfer knowledge of Lean Six Sigma, Change Management and Inclusion.

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
• Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute 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
• May be required to perform other duties as assigned

Qualifications

• 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
• 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