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 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 (our offer)
Comprehensive benefitsenjoy Udemy for Business, private medical care, Multisport card, veterinary package, language lessons, and shopping vouchers.Flexibilityadaptable working hours and remote / hybrid work options to suit your lifestyle & location.Career growthaccess opportunities for professional development and learning, including perks related to our official partnerships with global IT giants : Microsoft, AWS, Snowflake, Salesforce & more.Global collaborationwork with a diverse, international team.Innovative environmentbe 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 eventsincluding our company tradition (annual company event in Mazury).
A pleasant surpriseto start your journey with us in the form of a welcome pack.
Recruitment process :
HR callTechnical InterviewInterview with the dedicated ClientFinal decision / FeedbackSounds interesting? Click
"Apply"
and have a chance to hear more