Computerized System Validation Specialist

PerkinElmer Scientific (Switzerland) GmbH seeks a Computerized System Validation Specialist in Schachen to maintain validated states and manage system documentation for automated equipment.

Based at the customer site in Schachen, this position supports Customer Technology Lifecycle Excellence, IT, and various cross-functional departments. The specialist ensures that validated systems documentation remains current and compliant through regular reviews and active participation in validation projects.

Responsibilities

• Conducts regular assessments of documentation for validated systems to ensure ongoing compliance.
• Manages the decommissioning workflow and serves as the primary owner for related checklists.
• Creates and rolls out validation programs for automated machinery and operational processes.
• Supports change management and deviation tracking, including the handling of CAPA actions.
• Collaborates with Lifecycle & Compliance teams to review equipment and instruments periodically.
• Detects specification inconsistencies across existing installations to aid harmonization efforts.
• Processes changes, temporary adjustments, deviations, and CAPAs arising from periodic reviews.
• Acts as an author or executor during the validation of new systems.
• Engages in investigations and change initiatives as part of cross-functional groups.

Requirements

• Solid understanding of FDA regulatory standards.
• Familiarity with cGMP and validation rules.
• Proven experience in writing, reviewing, and approving validation records.
• Working knowledge of the software development lifecycle (SDLC).
• Excellent written and verbal communication abilities in English.

Nice to have

• Awareness of GCP, GVP, GMP, GDP, and GLP standards.
• Prior exposure to the Kneat eVal environment.
• Proficient German language skills.
• Ability to communicate in languages other than English and German.

What the company offers

• Dedication to professional growth with opportunities for learning and advancement.

About the company

PerkinElmer Scientific (Switzerland) GmbH strives to create positive impacts for its workforce while contributing meaningfully to global progress.

• Focus on employee well-being and professional development.
• Commitment to making a difference in the world.