Validation Lead - Global CSV & Compliance (Remote)

Billennium; Warszawa; Hybrid; PLN 180,000 - 280,000; Full time

Benefits offered by this job

Udemy for Business

Private medical care

Multisport card

Language lessons

Shopping vouchers

Job summary

Billennium is seeking a Validation Lead to ensure processes and systems comply with industry regulations and quality standards. You will create validation plans, monitor KPIs, and drive product validation while addressing data quality issues and regulatory requirements.

Global collaboration with product teams and audits will be part of the role. The ideal candidate brings proven pharma validation experience, hands-on CDS validation skills, and strong documentation and communication abilities in

Qualifications

• Proven experience as a Validation Analyst or senior validation role in a pharmaceutical industry.
• Strong hands-on experience with CDS validation (e.g. Empower, Chromeleon, OpenLab or similar).
• Solid knowledge of CSV, GXP, and data integrity principles.
• Experience in software development lifecycle processes (SDLC), models, standards in pharmaceutical industry.
• Excellent documentation and stakeholder communication skills.
• Fluent English in speech and writing (C1).

Responsibilities

• Creating and reviewing validation plans and reports in accordance with procedures.
• Monitoring key performance indicators and conducting comprehensive product validation.
• Identifying and analyzing data quality issues and providing solutions.
• Collaborating with quality assurance teams to meet regulatory requirements (e.g. GDPR, HIPAA, FDA 21 CFR Part 11).
• Coordinating validation activities globally and working with product teams.
• Preparing documentation for audits and inspections as a validation expert.

Skills

CDS validation

CSV

GXP

SDLC

Documentation

Stakeholder communication

English (C1)

Tools

Empower

Chromeleon

OpenLab

Job description

Billennium is seeking a Validation Lead to ensure processes and systems comply with industry regulations and quality standards. You will create validation plans, monitor KPIs, and drive product validation while addressing data quality issues and regulatory requirements.

Global collaboration with product teams and audits will be part of the role. The ideal candidate brings proven pharma validation experience, hands-on CDS validation skills, and strong documentation and communication abilities in