Process Validation Engineer
(Science or Engineering background)
Siemens Healthcare Diagnostics Manufacturing Limited (part of Siemens Healthineers) has an opening for a Process Validation Engineer with specialization in Materials science at our site in Swords, County Dublin.
Process Validation & design change verifications
1. Responsible for the site master validation plan and for leadership of all process validation activity on site. Active member of Validation review board.
2. Responsible for input into design change and process change verifications in order to meet optimum regulatory and technical standard. Full time member of design change review board and deviation review board.
3. Act as key liaison and knowledge transfer champion among Manufacturing engineering, R&D, Document control and Quality assurance in order achieve overall excellence. Ability to develop into a mentor role for the team is desirable.
4. As a key member of cross disciplinary engineering team you will also have the opportunity to contribute directly to the development of engineering solutions for both product and process
As a member of the site Engineering team you will specialize in compiling and reviewing technical reports to meet technical and regulatory standards of excellence.
Technical reports cover a broad range of activities, including verification, validation of product and process changes, risk assessment, technology transfer plans, equipment commissioning, deviations, corrective and preventative actions documents.
Refinement and update of internal engineering and quality system procedures in order to achieve both lean and fully compliant process.
Act as key knowledge leader within the Engineering team and interface point to local 3rd level institutions and external analytical labs to analyze and diagnose material related problems using most relevant analytical technique, (e.g. SEM, FTIR, Mass Spec, X ray Plastic molding analysis etc.)
Act as a knowledge leader in guiding internal laboratory practice in formulation of test standards and reagents for instrument testing, re-composition of standards, preparation of test reagents, correlations and equivalence.
The successful candidate will report to a Principal Engineer and will be a member of the site level Engineering Team at Swords.
Qualifications/Skills/Experience for this role:
Applications to firstname.lastname@example.org or telephone 8132170.