Senior Validation Analyst / Validation Lead
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.
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
Final decision/ Feedback
Sounds interesting? Click "Apply" and have a chance to hear more!