Quality Assurance Specialist

Saudi BioClean is a Jeddah-based company in its establishment phase. We are building specialist contamination-control and decontamination services for hospital cleanrooms, isolation units and pharmaceutical facilities in Saudi Arabia. We’re looking for a QA Specialist with hands-on microbiology and cleanroom experience. Your job will be to prove that our decontamination works: designing and running the tests that show surfaces, air and critical areas meet the required microbial and viral reduction levels, and documenting every result to audit standard. What you’ll do • Design and run decontamination validation studies for cleanrooms, isolation rooms, operating theatres and pharmaceutical grade areas (A–D / ISO 5–8). • Verify disinfectant and room-decontamination effectiveness against viruses, bacteria, fungi and spores. This includes hydrogen peroxide vapour/mist (HPV/VHP) and UV-C cycles. • Use biological indicators (e.g. Geobacillus stearothermophilus) and chemical indicators to confirm cycle effectiveness and log reduction • Run surface sampling (contact plates, swabs, ATP), active and passive air sampling (settle plates) and non-viable particle counts. • Apply virucidal and surface-efficacy testing principles (EN 14476, EN 13697, EN 17272), including surrogate organisms where appropriate. • Set alert/action limits, trend environmental monitoring data and investigate excursions • Manage deviations, OOS/OOT results, CAPA and change control linked to decontamination performance • Write and maintain validation protocols and reports, SOPs and cleaning/decontamination records (GDP / ALCOA+) • Support client audits and regulatory inspections What we’re looking for • Bachelor’s degree in Microbiology, Pharmacy,Biotechnology or a related life science • 5+ years in QA or QC microbiology in a pharmaceutical cleanroom, sterile manufacturing, hospital infection control or testing laboratory • Hands-on experience with environmental monitoring and disinfectant/decontamination validation • Working knowledge of EU GMP Annex 1, ISO 14644-1/-2 and USP /; familiarity with USP / is a plus • Understanding of aseptic technique, microbial identification and log-reduction calculations • Experience with hospital pathogens of concern (e.g. C. auris, MRSA, C. difficile spores, enveloped and non-enveloped viruses) is a strong advantage • Clear technical writing and strong attention to detail • Fluent English; Arabic is a strong advantage • Based in Jeddah or willing to relocate Why join us • You’ll be part of the founding phase of a company bringing scientific, evidence-based decontamination to Saudi hospitals and pharmaceutical facilities. You’ll help build the testing and validation standards our services run on, from day one. • Skills : Environmental Monitoring · Cleanroom · Microbiology · Disinfectant Efficacy Testing · Decontamination Validation · Biological Indicators · Good Manufacturing Practice (GMP) · CAPA · ISO 14644 · Aseptic Technique

Bachelor’s degree in Microbiology, Pharmacy, Biotechnology or a related life science; 5+ years in QA or QC microbiology in a pharmaceutical cleanroom, sterile manufacturing, hospital infection control or testing laboratory; Hands-on experience with environmental monitoring and disinfectant/decontamination validation; Working knowledge of EU GMP Annex 1, ISO 14644-1/-2 and USP <1072>/<1116>; familiarity with USP <797>/<800> is a plus; Understanding of aseptic technique, microbial identification and log-reduction calculations; Experience with hospital pathogens of concern (e.g. C. auris, MRSA, C. difficile spores, enveloped and non-enveloped viruses) is a strong advantage; Clear technical writing and strong attention to detail; Fluent English; Arabic is a strong advantage; Based in Jeddah or willing to relocate

Design and run decontamination validation studies for cleanrooms, isolation rooms, operating theatres and pharmaceutical grade areas (A–D / ISO 5–8); Verify disinfectant and room-decontamination effectiveness against viruses, bacteria, fungi and spores, including hydrogen peroxide vapour/mist (HPV/VHP) and UV-C cycles; Use biological indicators (e.g. Geobacillus stearothermophilus) and chemical indicators to confirm cycle effectiveness and log reduction; Run surface sampling (contact plates, swabs, ATP), active and passive air sampling (settle plates) and non-viable particle counts; Apply virucidal and surface-efficacy testing principles (EN 14476, EN 13697, EN 17272), including surrogate organisms where appropriate; Set alert/action limits, trend environmental monitoring data and investigate excursions; Manage deviations, OOS/OOT results, CAPA and change control linked to decontamination performance; Write and maintain validation protocols and reports, SOPs and cleaning/decontamination records (GDP / ALCOA+); Support client audits and regulatory inspections