Computerized System Validation Specialist

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

We’re looking for a Computerized System Validation Specialist to join our team on the Customer site, in Schachen.

The CSV Specialist 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.

Executes Decommissioning process, acting as document owner for Decommissioning Check List (DCL).

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.

More information about our OneSource services: OneSource Laboratory Solutions | PerkinElmer

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.

Join our Team!

We are strongly committed to the development of your career and giving you opportunities to learn and grow.

We make a difference for you while you make a difference in the world!