Global CSV Validation Specialist for Life Sciences

ProductLife Group; Scandicci; On-site; EUR 35,000 - 45,000; Full time

Job summary

ProductLife Group is seeking an experienced CSV and validation professional to impact global healthcare. The role focuses on planning, executing, and coordinating Computerized System Validation activities for client projects in strict regulatory alignment with GAMP 5, GMP, Annex 11 and 21 CFR Part 11.

You will prepare validation documentation, support data integrity, perform risk assessments, and drive lifecycle activities in collaboration with QA, IT, Engineering, Manufacturing and Validation

Qualifications

• Bachelor's or Master's degree in a related field.
• Strong knowledge of GxP and GMP requirements for computerized systems.
• Experience with CSV lifecycle and validation methodologies.
• Understanding of SDLC and lifecycle management for validated systems.
• Proficiency in MS Office tools (Word, Excel, PowerPoint).

Responsibilities

• Plan, coordinate and execute CSV activities for client projects in compliance with GAMP 5, GMP, EU GMP Annex 11 and 21 CFR Part 11.
• Prepare, review and manage validation documentation including validation plans, risk assessments, and validation reports.
• Support Data Integrity compliance according to ALCOA+ principles and applicable regulations.
• Perform risk assessments to define validation strategies and support regulatory compliance.
• Assist Change Control, Deviations, CAPAs and periodic validation lifecycle activities.
• Collaborate with cross-functional client teams to deliver validation projects on time and to spec.

Skills

GxP knowledge

CSV lifecycle

GAMP 5/Annex 11/Part 11

SDLC understanding

MS Office (Word/Excel/PowerPoint)

Attention to detail

Teamwork / collaboration

Education

Bachelor's or Master's in Engineering/CS/IT/Life Sciences/Pharmacy/Chemistry/Biotechnology

Tools

MS Office Suite

Job description

ProductLife Group is seeking an experienced CSV and validation professional to impact global healthcare. The role focuses on planning, executing, and coordinating Computerized System Validation activities for client projects in strict regulatory alignment with GAMP 5, GMP, Annex 11 and 21 CFR Part 11.

You will prepare validation documentation, support data integrity, perform risk assessments, and drive lifecycle activities in collaboration with QA, IT, Engineering, Manufacturing and Validation