Description:
Our client, a multinational pharmaceutical company, is seeking a Project Engineer to join its expanding team in its Limerick site.
This role is responsible for the management of the Water Room and Formulations process to ensure adequate supply of Di Water, Formulations is provided to the Manufacturing operation in a compliant manner.
Job Duties:
- Responsible for all water room and formulations process’ – including validation and on site coordination of activities and contractors in a regulated environment.
- Management of the maintenance system, procedures, and improvement projects associated with the water room and formulations process’.
- Work with cross functional teams to develop and implement process improvements and projects in line with strategic site goals and objectives associated with the water room.
- Implementation an adherence of safety/environmental requirements on existing process’, and purchase and installation of all new waterroom and formulation equipment.
- Ensure effective closure on Quality System documents (Audit Actions, NCR’s, CAPA’s, CAIAs, etc) under their control.
- Ensure all maintenance, process developments, change control and system improvements for the Water Room are managed in accordance with the Quality management system.
- Management of a team of technicians supporting Water room and Formulations area.
Requirements:
- Degree in Marine/Mechanical/Industrial Chemistry/Process Engineering
- Experience with GMP Formulations process’ in a Medical Device or Pharmaceutical setting
- Minimum 7 yeas experience in a similar role - ideally in a high volume Medical Device or Pharmaceutical manufacturing company.
- Experience with CAD tools and drawing change control.
- Practical application of statistical analysis techniques.
- Knowledge of lean and 6-Sigma methodologies is an advantage.
- Knowledge of DI Water generation, distribution and specifications
- Knowledge of USP Standards
- Understanding of GMP, commissioning and validation activities
- Strong people and project management skills, and manage multiple vendors and contractors.
- Structured approach to operation/capacity optimization, failure analysis and problem solving