Manufacturing Engineer II

Works as a manufacturing engineer supporting all aspects of product transfer including the set-up of production lines in our Clonmel facility. Implements creative solutions to manufacturing challenges including new technologies and innovative techniques. Collaborates with other BSC manufacturing sites both virtually and during multi-site visits. Process ownership of defined area - owns and drives process and equipment improvements and drives strategic and cost projects. Support the transfer of the BSC Scope products to BSC Clonmel. Develop an in-dept knowledge of the manufacturing process for the scope's products including all aspects of production and process controls in-place on these manufacturing lines. Develop and perform equipment/software qualifications, Process characterisations, process validations and Test Method Validations in support of product transfer. Initiates and completes technical activities leading to new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company. Process owner for defined area and drives ownership of Engineering activities/methodologies with an emphasis on Equipment/Systems validation lifecycle to approved procedures and standards Demonstrates a wide knowledge of Manufacturing process technologies and ability to develop expertise quickly Evaluates and leads the implementation of new Equipment/processes through research, analysis, evaluation, selection of software designs, operating systems with identification/verification of requirements using engineering best practices.. An expert problem solver with understanding of engineering principles theories, concepts, practices and techniques. Coordinates and conducts technical investigation and documentation of non-conforming events and trends and develop technical investigation plans using BSC Engineering Essentials. Continuously improves process and work methodologies by interfacing with peers/cross-functional groups and analyzing activities to improve workflow and work processes. Incorporates business policies and procedures into task completion. Understands the business needs of the company and has knowledge of the customer needs of our business. Understands the business cycle and foresight of emerging technologies trends. Be part of a strong team culture around high expectations & high performance. Provide clear communication to stakeholders at key technical updates Hons Bachelors Degree in Engineering/Science essential 3+ years of experience in a manufacturing environment required. FDA experience highly desirable but not essential. Experience in Validation lifecycle