Process Engineer – Carlow – Contract – Pharmaceuticals.
NPI and Technology transfer experience is ideal for this role.

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

• 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
• Hybrid role once successful completion of training, occasional shift support as required based on program needs