Process & Technology Engineer, Carrigtwohill
Client: [Client information not provided]
Location: Carrigtwohill
Job Category: Other
EU work permit required: Yes
Job Reference: 8d03f6f961a0
Job Views: 2
Posted: 27.04.2025
Expiry Date: 11.06.2025
Job Description:
The Role: Reporting to the Program Lead, the Process & Technology Engineer/Scientist is responsible for the development, qualification, control, and optimization of new Chromatography Media manufacturing processes.
Responsibilities include:
* Develop expertise in the new Chromatography Media manufacturing process to become a subject matter expert and a key member of the new product introduction team, collaborating with U.S.-based R&D colleagues.
* Assist with setting up a small-scale lab in the Media manufacturing area, including feasibility trials and qualification of lab equipment.
* Support the conversion of lab-scale processes into large-scale, commercially viable operations.
* Assist with the development, installation, and qualification of full-scale production equipment, including process trials to determine process windows.
* Participate in qualification activities for full-scale production, including feasibility trials, engineering batches, OQ & PQ runs.
* Identify, develop, and implement process improvement projects using lean six sigma tools.
* Support data collection systems and analytical techniques such as SPC, FMEA, Risk Assessments, and DOE.
* Evaluate new technologies and raw materials for potential use, including characterization and validation.
* Lead investigations into process, product, and quality issues, utilizing Root Cause Analysis and implementing corrective actions.
* Manage capital and process development projects within the plant, ensuring projects are delivered on time, within budget, and meet stakeholder expectations.
* Support management of plant BOMs and COR systems; develop expertise in SAP ERP system.
* Develop and operate process monitoring/control systems, review data for trends and weaknesses.
* Maintain and update process documentation and procedures.
* Collaborate with stakeholders such as Quality, Validation, Maintenance, and EHS to meet objectives.
* Ensure process information is documented and updated in Process Knowledge documents.
* Ensure compliance with GMP and safety regulations on all equipment and processes.
Qualifications:
* Degree in Chemistry, Chemical, or Process Engineering; postgraduate qualification preferred.
* Knowledge of leadership, change management, safety, quality, automated control systems, data analysis, Lean Six Sigma, Root Cause Analysis, project management, and GMP microbiological and aseptic design is advantageous but not mandatory.
#J-18808-Ljbffr