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Senior Validation Lead

Senior Validation Lead

BillenniumPolska
9 hours ago
Job description

More about us

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.

What you will do

  • 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

What we are looking for

  • 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 (our offer)

  • 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
  • Final decision / Feedback
  • Sounds interesting? Click

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    Senior Lead • Polska

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