Senior Validation Analyst / Validation Lead

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 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