Computerized System Validation Specialist

We are looking for experienced CSV professional to join our OneSource team at the Customer site in Schachen.

Role responsibilities:

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.

Requirements:

• Bachelor's degree in Information Systems, Engineering, Science or similar technical discipline or years of experience in similar position.

• Minimum 3 years of experience working in the Biotech/Pharmaceutical industry in Quality Compliance or Computer System Validation roles.

• 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 (would be beneficial). 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.