Process Engineer
We are seeking two experienced Process Equipment Engineers to join our team. The successful applicants will report to the Manufacturing Lead/Manufacturing Technology Lead and provide engineering support to ongoing requirements for Manufacturing as well as supporting any future tech transfer projects at our cutting-edge technology Vaccines Manufacturing Facility in Louth.
Responsibilities:
* Assist in site start-up and project-related activities, including commissioning 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 Factory Acceptance Testing (FAT) and vendor-related activities.
* Provide input to process mapping activities and review resulting Functional Design Specification (FDS) documents for accuracy and functionality.
* Participate in the commissioning of process equipment and associated automation as needed, and support issue resolution particularly in automation.
* Support the execution team by participating in verification & validation related activities as required.
* Ensure equipment is designed and tested to meet the requirements of the process, ensuring it continues to run as intended and 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 Corrective Action Preventative Actions (CAPAs) 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.
* 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, ensuring all data is ready in a timely fashion in support of OpU disposition metric.
* Perform additional duties at the request of the direct manager.
* Perform all duties in accordance with Good Manufacturing Practices (GMP) requirements, Standard Operating Procedures (SOPs), and controlled documents.
* Be flexible to take on additional tasks and responsibilities at the discretion of the Manufacturing Lead/Manufacturing Technology Lead.
* 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.
Requirements:
* A minimum of 5 years' experience working in large-scale Biopharmaceutical/pharmaceutical manufacturing facility.
* Experience and knowledge of DeltaV (or equivalent) Management Configuration System (MCS) platform is essential.
* Familiarity with Bioreactor, Chromatography, and Ultra filtration production operations is desirable.
* Experience using DeltaV (or equivalent) MCS platform in a commissioning or process development environment.
* Thorough knowledge of current Good Manufacturing Practices (cGMP).
Qualifications:
* A Third level qualification in a Science or Engineering related subject.