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Senior Validation Analyst / Validation Lead
Billennium · Warszawa · Posted 11d ago
About the role
More about usBillennium 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 roleWe 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 systemsAuthor validation plans/reports, reviews test plans/reports (and other deliverables) to asses and notify that system is ready to go lifeDetermine testing strategy, requirements and acceptance criteriaAssess changes to determine potential impact to the validated state of the computerized systemSupport system maintenance with validated state and permanent audit readinessSupport system audit/inspection preparation and execution as CSV subject matter expertAssures strategic/essential oversight over validation support within department and provides support/consultancy for the team and within global organization if necessaryRequirements:5-6+ years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environmentExperience in leading validation for projects and systems maintenanceExperience 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 11Ability to share knowledge and guide othersFluent English in speech and writingPerks 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 callTechnical InterviewInterview with the dedicated ClientFinal decision/ Feedback Sounds interesting? Click 'Apply' and have a chance to hear more!
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FAQ
Is the Senior Validation Analyst / Validation Lead role at Billennium remote?+
This Senior Validation Analyst / Validation Lead position is listed as remote (Warszawa).
What seniority level is this Senior Validation Analyst / Validation Lead role?+
This is a senior level position.
How do I apply for the Senior Validation Analyst / Validation Lead role at Billennium?+
Use the "Apply on justjoinit" button to open the original posting on justjoinit, where you can submit your application directly to Billennium.