Computerized System Validation Specialist

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

When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services.

Job Title

Computerized System Validation Specialist

Location(s)

MSD (Switzerland) - Customer Site

Job Description

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

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!