Senior Sterility Assurance Specialist / Reyndur sérfræðingur í dauðhreinsun og örveruöryggi

Við leitum að reynslumiklum sérfræðingi í dauðhreinsun og örveruöryggi til að ganga til liðs við teymið okkar á spennandi vaxtarskeiði. Í þessu hlutverki munt þú gegna lykilhlutverki í að móta og styrkja aðferðir okkar í smitgát, dauðhreinsun og örverustýringu í bæði virkniefna‑ (DS) og lyfjaformunarframleiðslu (DP).

Þú munt starfa í kraftmiklu og samvinnumiðuðu umhverfi, þar sem þú kemur fram sem faglegur leiðtogi og sérfræðingur á sviði dauðhreinsunar. Hlutverkið felur í sér að styðja við samræmi við alþjóðlega staðla, taka virkan þátt í stöðugum umbótum og hafa bein áhrif á framúrskarandi framleiðslu, gæði og langtímaárangur fyrirtækisins.

(English)

We are looking for an experienced Sterility Assurance Senior Specialist to join our team at an exciting phase of growth. In this role, you will play a central part in shaping and strengthening aseptic processing and microbial control strategies across our drug substance (DS) and drug product (DP) manufacturing operations.

You will work in a dynamic and collaborative environment, acting as a subject‑matter expert in sterility assurance, supporting compliance with international standards, and driving continuous improvement initiatives that directly impact our manufacturing excellence and long‑term success.

Key Responsibilities:

• Contribute to the documentation and management of microbial control strategies from incoming goods to final product.
• Provide oversight and sterility assurance expertise to ensure aseptic processing meets international standards.
• Monitor facility and quality systems compliance, develop action plans to address deficiencies, and improve processes.
• Lead and support investigations related to environmental monitoring, personnel monitoring excursions, deviations, CAPAs, and complaints.
• Collaborate with manufacturing teams on media fill simulations, intervention monitoring, and trending.
• Perform quality risk assessments for sterility assurance programs, including aseptic practices, environmental monitoring, sterilization, and aseptic process simulations.
• Support internal inspections, regulatory, and client audits.
• Author, review, and approve GMP documents such as SOPs, batch records, protocols, and reports.
• Act as SME for deviations, CAPAs, and change controls related to sterility assurance.
• Train, coach, and mentor less experienced staff in aseptic behaviors and cleanroom practices.
• Ensure quality metrics and KPIs are maintained within control for areas of responsibility.

Qualifications:

• Education: BSc degree in Pharmacy, Microbiology, or a relevant scientific discipline.
• Experience: Minimum 8+ years of direct industry experience in pharmaceutical or biopharmaceutical manufacturing, with strong knowledge of cGMP standards for aseptically produced drug products.
• Expertise in sterility assurance, contamination control strategies, and aseptic processing.
• Strong understanding of environmental monitoring, gowning regimes, cleaning regimes, and disinfectant efficacy studies.
• Experience with regulatory inspections and audit readiness.
• Excellent communication, problem-solving, and leadership skills.