Pharma Validation Lead (CSV) – Remote/Hybrid

Billennium; Polska; Hybrid; PLN 180,000 - 270,000; Full time

Benefits offered by this job

Udemy for Business

Private medical care

Multisport card

Veterinary package

Language lessons

Shopping vouchers

Flexible working hours

Career growth opportunities

Global collaboration

Innovative environment

Team-building events and CSR

Job summary

Billennium is seeking a Validation Lead to join a client project in the pharmaceutical industry. The role focuses on validation strategy, planning, and ensuring the validated state and audit readiness of GXP computerized systems.

Ideal candidate has 5–6+ years in IT validation, experience leading validation efforts, and strong knowledge of CFR 21 Part 11. English fluency is required and hybrid/remote options are available.

Qualifications

• 5–6+ years in IT validation (CSV, GAMP) in pharma context.
• Experience leading validation for projects and maintenance.
• Familiar with SDLC processes in regulated environments.
• Experience maintaining validated state and audit readiness.
• Fluent in English (spoken and written).

Responsibilities

• Define validation approach and required deliverables.
• Author validation plans/reports and review plans/reports for readiness.
• Determine testing strategy, requirements and acceptance criteria.
• Assess changes for impact on validated state.
• Support audit readiness and inspections as CSV SME.
• Provide guidance within the department and globally.

Skills

CSV validation

GAMP

SDLC knowledge

Pharma regulatory

Leadership

English proficiency

Tools

CFR 21 Part 11

Job description

Billennium is seeking a Validation Lead to join a client project in the pharmaceutical industry. The role focuses on validation strategy, planning, and ensuring the validated state and audit readiness of GXP computerized systems.

Ideal candidate has 5–6+ years in IT validation, experience leading validation efforts, and strong knowledge of CFR 21 Part 11. English fluency is required and hybrid/remote options are available.