Manufacturing (Process) Engineer
- Tipperary
- Permanent
- Full-time
Due to continued expansion Manufacturing Engineers required to support a product transfer involving the setup of a manufacturing line including all aspects of the validation life cycleResponsibilities:
- Develop an in-depth 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
- Continuously improves process and work methodologies by interfacing with peers/cross-functional groups and analyzing activities to improve workflow and work processes.
- Provide clear communication to stakeholders at key technical updates
- 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