- Cork city
- 50000 - 60000
- Permanent full-time
- Updated 17/02/2017
- Brid Gallagher
Project Engineer required for a manufacturing environment based in Cork. Engineering qualification with previous experience of working within a GMP environment.
The successful candidates will plan, design, coordinate, validate and implement high technology equipment and/or processes for the site. He/she will also provide engineering support to ensure high yields and minimize downtime of process equipment prior to implementation into production.
- Responsible for introducing and validating new equipment and/or complex new process projects from design through completion and in compliance with regulatory requirements.
- Responsible for project management & planning and for liaising with other departments affected by these projects. Also for reporting project status to management and highlighting areas of concern early.
- Responsible for ensuring all projects are completed to agreed timelines and within budget.
- Responsible for planning and managing equipment implementation to ensure effective utilization of multi departmental resources both internal and external to the company.
- Assigned work adheres to EHSE requirements.
- Ensure continual Quality System compliance by adherence to established Client requirements
- Author and/or review and approval of protocols, technical reports, SOPs, and technical specifications. Compilation of technical documentation for regulatory submissions.
- Responsible for applying cost improvement and LEAN Manufacturing initiatives in projects.
- Responsible for optimising new processes through process analysis and the application of engineering principles.
- Manages assignments / project works performed by outside vendors
- Provide Support to the engineering department when required.
- Knowledge of process engineering, equipment, automation specification and GMP validation requirements.
- Bachelor's degree in Process; Chemical; Mechanical; Electrical Engineering or other related discipline.
- Project Management Qualification desirable
- Experience of current cGMP requirement of an FDA/HPRA approved facility
- PC and software proficiency - Microsoft software and Microsoft project
- 3-5 years + experience in API Production environment with experience of process engineering and equipment validation.