Process Engineer
We are seeking two skilled Process Equipment Engineers to join our team at our cutting-edge technology Vaccines Manufacturing Facility in Louth.
Key Responsibilities:
* Support site start-up and project-related activities, including CQV and automation testing.
* Collaborate with 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.
* Commission process equipment and associated automation as needed, supporting issue resolution particularly in automation.
* Contribute to verification and validation related activities as required.
* Evaluate equipment design and testing to ensure compliance with process requirements.
* Coordinate the delivery of a robust process and reliable equipment in support of a Right First Time Operating Unit.
* Implement equipment corrective action and performance improvements.
* Offer technical support and troubleshooting for equipment.
* Provide routine automation support, troubleshooting, and maintenance.
* Support the implementation of Global Requirement Program tools and techniques within the Operation Unit.
* Utilize PI to enhance business efficiency.
* Identify opportunities for improvement projects.
* Work with portfolio management to identify project demands from Core Units.
* Champion energy-saving initiatives.
* Write equipment assessments to support investigation closure.
* Manage change control write-ups and close-outs.
* Closure investigations in a timely manner.
* Perform additional duties as requested by direct manager.
* Adhere to GMP requirements, SOPs, and controlled documents.
Person Specification, Experience and Knowledge Requirements:
* Minimum 5 years' experience in large-scale Biopharmaceutical/pharmaceutical manufacturing facility.
* Essential experience and knowledge of DeltaV (or equivalent) MCS platform.
* Familiarity with Bioreactor, Chromatography, and Ultra filtration production operations is desirable.
* Experience using DeltaV (or equivalent) MCS platform in commissioning or process development environment.
* Thorough knowledge of current Good Manufacturing Practices (cGMP).
Qualifications:
* Third-level qualification in a Science or Engineering related subject.
Onerous Requirements:
* Willingness to travel internationally as required to fulfill responsibilities.