CSV Specialist: Validated Systems & Lifecycle Expert

PerkinElmer; Canton (OH); On-site; USD 111,000 - 160,000; Full time

Job summary

PerkinElmer is seeking a Computerized System Validation Specialist to support on-site activities at the Schachen site. You will review validated systems, manage CAPA, deviations, and changes, and collaborate with QA and IT to optimize the CSV program across equipment and information management systems.

Ideal candidates have strong knowledge of FDA, GxP, GDP/GLP, and SDLC, plus experience authoring validation documents. German language skills are a plus; English is required.

Qualifications

• Knowledge of FDA regulations and validation standards.
• Experience authoring/reviewing validation documentation.
• Understanding of CGMP and validation practices.
• Familiarity with FDA/ICH guidelines and GDP/GLP concepts.
• Experience in SDLC and cross-functional team collaboration.
• Knowledge of Kneat eVal is a plus.

Responsibilities

• Perform periodic reviews of validated systems documentation.
• Lead or contribute to CAPA, deviations, and change management.
• Collaborate with Lifecycle, IT, and QA to harmonize specs.
• Participate in new system validation projects and investigations.

Skills

FDA regulations

cGMP & validation

GCP, GVP, GMP, GDP, GLP

Validation documentation

SDLC

Kneat eVal

Customer service mindset

Attention to detail

English & German communication

Teamwork & independence

Multi-project management

Education

null

Tools

Kneat eVal

Job description

PerkinElmer is seeking a Computerized System Validation Specialist to support on-site activities at the Schachen site. You will review validated systems, manage CAPA, deviations, and changes, and collaborate with QA and IT to optimize the CSV program across equipment and information management systems.

Ideal candidates have strong knowledge of FDA, GxP, GDP/GLP, and SDLC, plus experience authoring validation documents. German language skills are a plus; English is required.