Job Description
Process Engineer x 2
Role Description The successful Process Equipment 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 client's cutting-edge technology Vaccines Manufacturing Facility in Louth.
Responsibilities
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.
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 that validated state.
Coordinate the 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 the implementation of Global Requirement Program tools and techniques within the Operation Unit (e.g., Operator Care, Pd M, PMO, Work Management).
Support the use of PI to provide business efficiency.
Identify equipment, process, and automation improvement projects as needed.
Work with the portfolio management process to identify projects/support demands from the 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 as applicable.
Support audit preparation.
Implement and support continuous improvements that reduce cycle times and operational costs.
Support the disposition process.
Ensure all data is ready in a timely fashion in support of Op U 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 the Manufacturing Lead/Manufacturing Technology Lead.
Will act as a role model for the Manufacturing function and also the wider organization in adherence to the client's corporate core values and PROUD culture.
Person Specification, Experience and Knowledge Requirements
Min 5 years' experience working in large-scale Biopharmaceutical/pharmaceutical manufacturing facility.
Experience and knowledge of Delta V (or equivalent) MCS platform is essential.
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 (c GMP).
Qualifications Third level qualification in a Science or Engineering related subject.
Onerous Requirements Must be willing to travel as required internationally to fulfill the responsibilities of the position.
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