Senior Validation Analyst / Validation Lead

Billennium; Polska; Híbrido; PLN 180 000 - 270 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

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

Resumo da oferta

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.

Qualificações

• 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).

Responsabilidades

• 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.

Conhecimentos

CSV validation

GAMP

SDLC knowledge

Pharma regulatory

Leadership

English proficiency

Ferramentas

CFR 21 Part 11

Descrição da oferta de emprego

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!

About the role

We are looking for an experienced Validation Lead who will join a project for our client in the pharmaceutical industry.

Key Responsibilities:

• Determine validation approach, identifies deliverables needed or impacted by a project / enhancement / or change for GXP computerized systems
• Author validation plans/reports, reviews test plans/reports (and other deliverables) to asses and notify that system is ready to go life
• Determine testing strategy, requirements and acceptance criteria
• Assess changes to determine potential impact to the validated state of the computerized system
• Support system maintenance with validated state and permanent audit readiness
• Support system audit/inspection preparation and execution as CSV subject matter expert
• Assures strategic/essential oversight over validation support within department and provides support/consultancy for the team and within global organization if necessary

Requirements:

• 5-6+ years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment
• Experience in leading validation for projects and systems maintenance
• Experience in software development lifecycle processes (SDLC), models, standards in pharmaceutical industry (or other regulated)
• Experience in maintenance and support of applications under global inspection agencies, CFR 21 FDA Part 11, Annex 11
• Ability to share knowledge and guide others
• Fluent English in speech and writing

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