Shift Process Engineer Contract
Responsible for providing process, technical, and validation support to operations for commercial manufacturing and Process Simulation development and execution. Accountable for all studies associated with the development of new components, products, processes systems, and facilities in relation to process simulations. Co-ordination, design, and execution of commercial & Process simulations studies as required.
- Technical Support: Serve as technical support for manufacturing and new product introduction.
- Process Simulations Studies: Design/Author/Review/Approve/Execute process simulations studies in support of new product introduction and ongoing manufacturing support.
- Quality Notification: Provide technical input into quality notification by authoring/reviewing/approving Process Simulation related investigations.
- Qualification/Validation Documentation: Design/Author/Review/Approve/Execute commercial & process simulation qualification/validation documentation and studies in line with the standard approval process.
- Data Analysis: Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
- Continuous Improvement: Support continuous improvement through Lean Six Sigma methodologies.
- Project Participation: Leading and active participation in projects, system failure investigations, and investigation reports.
- Change Controls: Execution/development of change controls to support the Process Simulation process.
- Root Cause Analysis: Perform root cause analysis of system failures, substandard performance, using standard tools and methods.
- Global Representation: Serve as technical engineering representative for internal technical group discussions and represent technical operations Carlow at global technical forums in relation to process simulations.
- Compliance: Drive compliance of Merck Global Policies, Procedures, and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP).
- Safety and Compliance Culture: Work collaboratively to drive a safe and compliant culture in Carlow.
Qualifications and Skills
- Bachelor's degree or higher in Science, Engineering, or a related technical discipline is required.
Regulatory and Writing Skills:
- Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
- Report, standards, and policy writing skills are required.
- Experience in equipment and process validation.
- Familiarity with sterile filling processes and equipment.
- Proficiency in Microsoft Office and job-related computer applications.
- Lean Six Sigma Methodology experience desired.
Communication and Interpersonal Skills:
- Excellent communication, presentation, and interpersonal skills.
- Understanding of specific responsibilities of all Carlow departments.
- Customer service and vendor liaison skills.
- Strong influencing and negotiation skills.
Management and Analytical Skills:
- Effective time management and multi-tasking skills.
- Excellent attention to detail and trouble-shooting skills.
- Data analysis and goal/results-oriented approach.
- Demonstrable analytical and systematic problem-solving skills.
- Training skills, change management skills, and business acumen.
- Strategy development, project management, and risk management skills.
- Progressive people management skills.
- Ability to effectively manage complex projects across multiple disciplines.
If you are interested in this opportunity and meet the requirements, please contact Eoghan Colton on 086 839 5533 or firstname.lastname@example.org
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