Computerized System Validation Specialist

PerkinElmer; Schweiz; Vor Ort; EUR 107.411 - 150.375; Vollzeit

Zusammenfassung

PerkinElmer seeks a Computerized System Validation Specialist to join the customer-site team in Schachen. The CSV Specialist reviews validated systems documentation to ensure ongoing validated state, considering device lifecycle and norms evolution.

You will participate in decommissioning, CAPA, and change management, collaborating with Lifecycle Excellence, IT and QA, and may author or execute new validation projects.

Qualifikationen

• Strong knowledge of FDA regulations and validation requirements.
• Experience with GDP, GMP, GCP and GLP.
• Experience authoring/reviewing validation documentation.
• Ability to work independently and in cross-functional teams.

Aufgaben

• Review validated systems documentation to ensure ongoing validation.
• Execute decommissioning process and own Decommissioning Check List (DCL).
• Collaborate with Lifecycle Excellence, IT and QA to implement CSV programs.
• Contribute to CAPA, change management and deviation tracking.
• Author or execute new system validation projects with cross-functional teams.

Kenntnisse

English fluency

German language skills

Attention to detail

Cross-functional collaboration

Independent 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. 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! Are you ready to help improve the lives of millions of people and create a healthier world? When you work at PerkinElmer, that’s exactly what you’ll do. From our dedicated scientists and world‑class operations employees to our innovative R&D professionals and committed sales and service groups, we’re a unique team of 5,000+ global colleagues who come to work every day knowing we’re making a difference. Through innovation, collaboration, and believing in our mission, we strive to create an inspiring and inclusive culture for our employees, so that they can be their best and, together, create a better tomorrow. Join us today.