CSV Specialist: Validate & Harmonize Lab Systems On-Site

PerkinElmer; Schachen; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

PerkinElmer in Schachen, Switzerland is seeking a Computerized System Validation Specialist to support on-site CSV activities for Laboratory and Manufacturing operations.

You will perform periodic reviews of validated systems, author and review validation documentation, and collaborate with Customer QA, IT and cross-functional teams to ensure continued validated state in line with FDA regulations and GxP standards.

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 Kneat eVal experience is 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).
• 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

• Perform periodic reviews of validated systems (equipment and instruments).
• Contribute to harmonization projects by identifying specification discrepancies across the installed base.
• Process Changes, Temporary Changes, Deviations, and CAPA related to periodic review findings.
• 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.

Kenntnisse

FDA regulations

cGMP

GxP compliance

GCP

GDP

GLP

GMP

GVP

validation documentation

SDLC

attention to detail

communication in English

German language

multi-project management

Jobbeschreibung

PerkinElmer in Schachen, Switzerland is seeking a Computerized System Validation Specialist to support on-site CSV activities for Laboratory and Manufacturing operations.

You will perform periodic reviews of validated systems, author and review validation documentation, and collaborate with Customer QA, IT and cross-functional teams to ensure continued validated state in line with FDA regulations and GxP standards.