Senior CSV Validation Engineer – GxP Data Integrity Lead

Genezen; Lexington (VA); On-site; USD 115,000 - 140,000; Full time

Benefits offered by this job

Paid vacation days

Paid sick time

401(k) plan with company match up to 6

Dental & vision care

FSA and HSA programs

Job summary

Genezen in Lexington, MA (and Fishers, IN) is seeking a Senior Validation CSV to lead computerized systems validation projects across laboratory, manufacturing, and quality systems. You will develop and execute risk-based validation strategies, generate protocols and documentation, and ensure data integrity in accordance with FDA, EU, and ISO guidance.

The ideal candidate has 7+ years of CSV experience, a bachelor's in engineering or computer science, and strong technical writing and project

Qualifications

• Bachelor's degree in Engineering, Computer Science or related field.
• 7+ years of Computer System Validation experience.
• Strong knowledge of GxP validation principles and data integrity.

Responsibilities

• Lead risk-based validation strategies for GxP computerized systems across the lifecycle.
• Review and approve qualification documentation on behalf of validation.
• Ensure compliance with FDA, EU, ISO and Data Integrity guidance and internal procedures.

Skills

Communication

Data integrity

Regulatory knowledge

Project management

Technical writing

cGMP knowledge

21 CFR Part 11

MS Office

Adobe Acrobat

Education

Bachelor's degree in Engineering/Computer Science

Job description

Genezen in Lexington, MA (and Fishers, IN) is seeking a Senior Validation CSV to lead computerized systems validation projects across laboratory, manufacturing, and quality systems. You will develop and execute risk-based validation strategies, generate protocols and documentation, and ensure data integrity in accordance with FDA, EU, and ISO guidance.

The ideal candidate has 7+ years of CSV experience, a bachelor's in engineering or computer science, and strong technical writing and project