Website Asset Recruitment
Process Engineer x 2
The successful Process Engineer applicant will report to the Manufacturing Lead/Manufacturing Technology Lead, and will support the activities of the Manufacturing Technology team with responsibility for providing engineering support to ongoing requirements for Manufacturing as well as supporting any future tech transfer projects at our clients cutting edge technology Vaccines Manufacturing Facility in Louth.
- Assist in site start up and project related activities (CQV and automation testing):
Support package owners on vendor management, equipment or automation related activities and queries.
- Review vendor automation documentation for completeness and accuracy.
- Participate in FAT and vendor related activities.
- Provide input to process mapping activities and review resulting Functional Design Specification (FDS) documents for accuracy and functionality. Also provide input to FDS document revisions as required.
- Participate in commissioning of process equipment and associated automation as needed.
- Support issue resolution as needed, particularly in automation.
- Support CQV execution team by participating in verification & validation related activities as required.
- Participate in verification & validation related activities as required.
- Support CQV execution team as needed.
- Ensure equipment is designed and tested to meet the requirements of the process, to ensure that the equipment continues to run as intended, that it is appropriately validated and maintained in validated state.
- Coordinate delivery of a robust process and reliable equipment in support of a Right First Time Operating Unit.
- Implement equipment CAPA’s and performance improvements
- Provide equipment technical support and troubleshooting.
- Provide routine Automation support, troubleshooting and maintenance.
- Support implementation of Global Requirement Program tools and techniques within the Operation Unit. (for e.g. Operator Care, PdM, PMO, Work Management)
- Support use of PI to provide business efficiency.
- Identify equipment, process and automation improvement projects as needed.
- Work with portfolio management process to identify projects/support demands from Core Units.
- Champion and Support Energy saving programs/projects within the Operating Unit.
- Write equipment assessments to support investigation closure.
- Change Control write up and close out.
- Ensure investigations are closed on time, recurring deviations are tracked, and that true root cause and effective CAPA are identified and implemented.
- Participate in cross-functional project teams
- Support audit preparation.
- Implement and support continuous improvements that reduce cycle times and operational costs.
- Support disposition process. Ensure all data ready in timely fashion in support of OpU disposition metric.
- Perform additional duties at the request of the direct manager.
- Perform all duties in accordance with GMP requirements, SOPs and controlled documents.
- Will be flexible to take on additional tasks and responsibilities at the discretion of Manufacturing Lead/Manufacturing Technology Lead.
- Will act as a role model for Manufacturing function and wider organisation in adherence to clients corporate core values and PROUD culture.
Person Specification, Experience and knowledge requirements
- Min 3+ years’ experience working in large-scale in a Biopharmaceutical/pharmaceutical manufacturing facility.
- Experienced and knowledgeable of Delta V (or equivalent) MCS platform is essential.
- Experienced in supporting tech transfer, drawing up process flow diagrams, supporting trials.
- Experienced in ensuring equipment is designed and tested to meet requirements of process and runs as intended, validated and maintained in validated state.
- Familiarity with Bioreactor, Chromatography and Ultra filtration production operations is desirable.
Experience using Delta V (or equivalent) MCS platform in a commissioning or process development environment.
- Thorough knowledge of current Good Manufacturing Practices (cGMP).
- Third level qualification in a Science or Engineering related subject Behavioural Competencies
- Must be willing to travel as required internationally to fulfil the responsibilities of the position.