CSV Specialist: Validate Automated Lab Systems

PerkinElmer; Lavamünd; Vor Ort; EUR 117.000 - 160.000; Vollzeit

Zusammenfassung

PerkinElmer is seeking a Computerized System Validation Specialist to join our team at the Customer site in Schachen, supporting the Decommissioning and CSV program for automated equipment and information management.

You will collaborate with Customer Technology Lifecycle Excellence, IT, and QA to harmonize specifications, contribute to CAPA, changes, and periodic reviews, ensuring compliance with FDA regulations and GxP practices. Strong English is required; German is a plus.

Qualifikationen

• 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 about attention to detail and technical aspects.
• Strong written and verbal communication skills in English (required), German (strongly preferred).
• Ability to work both independently and as a team member, within prescribed guidelines, coping with frequent grey areas / uncertainty.
• Ability to manage multiple projects.

Aufgaben

• Execute Decommissioning process and own Decommissioning Check List (DCL).
• Develop and implement an efficient Computerized Systems Validation Program for automated equipment and information management.
• Harmonize specifications with QA and Technical Units; contribute to CAPA and deviation tracking.
• Participate as author or executor on new system validation projects, partnering with CSV team.
• Contribute to changes and investigations as a member of cross-functional teams.

Kenntnisse

FDA regulations

GMP (cGMP)

SDLC

Validation documentation

Attention to detail

Communication skills

English language

German language

Independent & team work

Project management

Tools

Kneat eVal

Jobbeschreibung

PerkinElmer is seeking a Computerized System Validation Specialist to join our team at the Customer site in Schachen, supporting the Decommissioning and CSV program for automated equipment and information management.

You will collaborate with Customer Technology Lifecycle Excellence, IT, and QA to harmonize specifications, contribute to CAPA, changes, and periodic reviews, ensuring compliance with FDA regulations and GxP practices. Strong English is required; German is a plus.