Job Description

Performs the periodic review of validated systems documentation, to grant systems continue to operate in a validated state, considering device life cycle and applicable norms evolution.

Works with Customer Technology Lifecycle Excellence, IT, and cross functional departments in development and implementation of an efficient Computerized Systems Validation Program for automated equipment, processes, and information management systems for the Laboratory and Manufacturing Operations.

Contribute with Customer QA and Technical Unit in harmonizing and implementing specifications. Contribute in change management and deviation tracking processes, including leading or contributing to CAPA. May contribute to developing procedures and/or protocols.

Periodic Reviews

Works closely with Lifecycle & Compliance team to perform periodic reviews of validated systems (both equipment and instruments) Actively contributes to harmonization projects by identifying specification discrepancies across the installed base at Customer site. Processes Changes, Temporary Changes, Deviations, and CAPA related with periodic review findings.

Computerized Systems Validation

Participate as author or executor to new system validation projects, partnering with Customer CSV team. Contributes to changes and investigations as a member of cross-functional teams.

Preferred Characteristics

Strong background and understanding of FDA regulations. Knowledge of cGMP and validation regulations and requirements. Knowledge of Good Clinical practice (GCP), Good pharmacoVigilance Practice (GVP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP). Experience in authoring/reviewing/approving validation documentation. Working knowledge of software development lifecycle (SDLC). Previous experience with Kneat eVal environment would be a plus. Developed Customer service mindset. Be passionate in attention to detail and tech aspects. Strong written and verbal communication skills in English (required), German (strongly preferred). Any additional language would be a plus. Ability to work both independently and as a team member, within prescribed guidelines, coping with frequent grey areas / uncertainty. * Ability to manage multiple projects.