Engineering , Science, Pharmaceutical & Food
Process Engineer – Purified Water/Formulations
PE Global is currently recruiting for a Process Engineer for a leading multi-national Med Device/Pharma client based in Limerick.
This is an initial 12-month contract position.
- Responsible for all water room and formulations processes – including validation and on-site co-ordination of activities and contractors in a regulated environment.
- Management of the maintenance system, procedures, and improvement projects associated with the water room and formulations processes.
- 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 and adherence to safety/environmental requirements on existing processes, and purchase and installation of all new water room and formulation equipment.
- Ensure effective closure on Quality System documents (Audit Actions, NCR’s, CAPA’s etc.) assigned
- 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 and operators supporting Water room and Formulations area.
- Degree qualified (NFQ Level 8) in Marine/Mechanical/Industrial Chemistry/Process Engineering or a related BSc/BEng.
- Ideally of 4 to 6 years’ experience in a similar role – ideally in a high-volume Medical Device or Pharmaceutical manufacturing company or additional engineering or management post-graduate qualifications in place of experience (NFQ Level 9).
- Previous experience with GMP water purification in a Medical Device, Combination product or Pharmaceutical setting or from other industries purifying water – Food/Beverages etc. Preference is for those with background in Chemical engineer, but can also be mechanical/process etc.
- Experience with CAD tools (e.g., AutoCAD, Microsoft Visio).
- Practical application of statistical analysis techniques (e.g., Minitab).
- 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 be able to manage multiple vendors and contractors.
- Structured approach to operation/capacity optimization, failure analysis and problem solving
Interested candidates should submit an updated CV.
Please click the link below to apply, call Seán on +353 21 4297900 or alternatively send an up to date CV to email@example.com
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***