Sterility Assurance Specialist

Title: Sterility Assurance SpecialistLocation: Reykjavík, Capital Region, Iceland (Relocation support provided)We are collaborating with a leading global biotechnology company that is expanding its manufacturing operations due to strong commercial success and an increasing focus on clinical development. The company has introduced some of the most innovative products on the market, leveraging cutting-edge technology. With a proven track record in both the US and EU markets, the company maintains a patient-centred approach, striving to enhance global access to critical biological medicines, including vaccines, insulin, and monoclonal antibody cancer therapies.Position Overview:Ensures aseptic integrity and contamination control in a state-of-the-art biosimilars manufacturing facility. Acting as a subject matter expert, you will drive continuous improvement and mentor colleagues in best practices for aseptic processing.Responsibilities: Manage and support microbial control strategy Provide sterility assurance and aseptic processing expertiseEnsure compliance with cGMP and global aseptic standardsLead and support EM, deviation, CAPA, and contamination investigationsCollaborate on media fills, risk assessments, and process improvementsSupport audits and maintain GMP documentationAct as SME for sterility assurance and change controlsStay current with regulations and mentor junior staffRequirements: 4+ Years of (Bio)Pharmaceutical GMP Sterile / Aseptic environmentSME in maintaining Sterile / Aseptic proceduresDegree in a scientific disciplineFluent in English