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