Validation Lead

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 a global technology company with over 20 years of experience, committed to innovation and empowering businesses. As an employer, we offer a supportive, growth-focused environment where collaboration and creativity thrive. Join us to shape the future of technology together!

What you will do:

As a Validation Lead, you will play a key role in ensuring compliance of processes and systems with industry regulations and quality standards. Your responsibilities will include:

• 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.

What we are looking for:

• Proven experience as a Validation Analyst or senior validation role in apharmaceutical industry.
• Strong hands-on experience withCDS 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).

Perks and benefits:

• Comprehensive benefits - enjoy Udemy for Business, private medical care, Multisport card, veterinary package, language lessons, and shopping vouchers.
• Flexibility - adaptable working hours and remote/hybrid work options to suit your lifestyle & location.
• Career growth - access opportunities for professional development and learning, including perks related to our official partnerships with global IT giants: Microsoft, AWS, Snowflake, Salesforce & more.
• Global collaboration - work with a diverse, international team.
• Innovative environment - be part of a forward-thinking and growth-oriented workplace.
• Engaging community - Work with passionate professionals and participate in team-building events, hackathons, and CSR initiatives to make an impact beyond work.
• Team-building events including our company tradition (annual company event in Mazury).
• A pleasant surprise to start your journey with us in the form of a welcome pack.

Recruitment process:

• HR call
• Technical Interview
• Interview with the dedicated Client