{"id":2893682,"url":"https://alion.io/job/alvotech-principal-specialist-qa-engineering","title":"Principal Specialist - QA Engineering","company":{"id":2394553,"name":"Alvotech","domain":"alvotech.com","url":"https://alion.io/company/alvotech","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"QA","role_family":"QA","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Reykjavík, Iceland"],"countries":["IS"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-10-19T00:00:00Z","employer_posted_date":"2026-10-19","last_verified_at":"2026-10-22T21:29:15Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"Key responsibilities and minimum requirements according to the role:\nProvide QA oversight and collaborate with cross-functional teams in planning maintenance, qualification, and validation activities for facilities, utilities, equipment, and computer systems (CSV).\nServe as a Quality representative and a subject matter expert (SME) in selection, design and build of new technologies and new facilities within Alvotech.\nSupport and provide QA oversight with review and approval of qualification documents for facility, utility, equipment and computerized systems as applicable.\nContribute to investigations into discrepancies arising during qualification / validation activities and subsequent approval of appropriate corrective actions.\nReview of planned and unplanned work orders for maintenance, preventive maintenance, calibrations and other Engineering related activities.\nReviews and approve change controls, deviations , CAPAs , effectiveness checks for facilities, utilities, and equipment, computer systems.\nStay current on applicable external requirements and industry standards and drive continuous\nimprovement on Engineering and CSV processes and tools.\nAdvice on quality matters, and assistance for closing compliance gaps found in audits and\ninspections.\nEscalation of any data integrity or critical quality issues to the supervisor and Quality Management of Alvotech\nResponsible for ensuring all facilities, utilities, equipment , computer systems are appropriately validated and qualification in line with current EU and US legislation for parenteral/biologics.\nMinimum education and experience required for the role:\nA bachelor’s degree within relevant area, or other relevant business experience\nMinimum 5 years of experience within the Pharmaceutical or Medical Device Industry (preferably in parenteral/biologics formulations).\nExperience working with regulatory requirements in GxP required (Preferably FDA and EU regulations).\nGood understanding of GAMP 5 guide required.\nKnowledge of and experience with validation and qualification specifically within facility, utility, and equipment/computer 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