Pharma Validation Lead - Remote/Hybrid Growth Role

Billennium; Polska; Hybrid; PLN 150,000 - 260,000; Full time

Benefits offered by this job

Udemy for Business

Private medical care

Multisport card

Language lessons

Shopping vouchers

Remote/hybrid work options

Job summary

Billennium is seeking an experienced Validation Lead to join a pharmaceutical project. The role focuses on leading validation efforts for GXP computerized systems, ensuring readiness for go-live and ongoing audit readiness.

The ideal candidate has 5-6+ years in IT/Software Validation (CSV, GAMP), strong SDLC knowledge, and fluent English. Remote/hybrid options are available to fit location and lifestyle.

Qualifications

• 5-6+ years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment.
• Experience leading validation for projects and systems maintenance.
• Experience in SDLC processes and pharmaceutical regulatory standards.

Responsibilities

• Determine validation approach and identify deliverables for GXP computerized systems.
• Author validation plans/reports and review test plans/reports to confirm readiness for go-live.
• Determine testing strategy, requirements and acceptance criteria.
• Assess changes for impact on validated state of systems.
• Support system maintenance with validated state and audit readiness.
• Support audit/inspection preparation and execution as CSV SME.
• Provide strategic oversight of validation support within the department and globally.

Skills

CSV validation

GAMP

People leadership

English fluency

Job description

Billennium is seeking an experienced Validation Lead to join a pharmaceutical project. The role focuses on leading validation efforts for GXP computerized systems, ensuring readiness for go-live and ongoing audit readiness.

The ideal candidate has 5-6+ years in IT/Software Validation (CSV, GAMP), strong SDLC knowledge, and fluent English. Remote/hybrid options are available to fit location and lifestyle.