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السعودية , جدة
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تفاصيل الوظيفة

???? We're Hiring: BFS Engineer (Blow-Fill-Seal) | Pharmaceutical Manufacturing Facility – Jeddah Industrial City, Saudi Arabia Section 1: ROLE PURPOSE To operate, maintain, and troubleshoot Blow-Fill-Seal (BFS) aseptic filling lines, ensuring uninterrupted, GMP-compliant sterile production of pharmaceutical products (IV solutions, plastic ampoules/vials), for a leading EU-GMP pharmaceutical manufacturing facility based in the Jeddah Industrial City. Section 2: KEY RESPONSIBILITIES / ACCOUNTABILITIES ⚙️ Operate and monitor BFS (Blow-Fill-Seal / Rommelag-type) machines during aseptic filling of sterile pharmaceutical products ⚙️ Perform mold/format changeovers, in-process parameter adjustments, and line clearance ⚙️ Diagnose and resolve mechanical, pneumatic, and electrical faults on BFS lines to minimize downtime ⚙️ Execute preventive and corrective maintenance on BFS equipment per maintenance schedules ⚙️ Support IQ/OQ/PQ qualification and validation activities for BFS systems ⚙️ Ensure strict compliance with GMP, EU-DRALEX, and SFDA regulatory requirements ⚙️ Maintain accurate batch records, maintenance logs, and deviation documentation ⚙️ Support investigations related to equipment-linked OOS/OOT and deviations, and implement CAPAs ⚙️ Ensure proper cleaning, sanitation, and sterility assurance of BFS equipment ⚙️ Support internal/external audits and regulatory inspections related to BFS operations Section 3: KEY INTERACTIONS Internal: Production Manager, Engineering/Maintenance Department, QA, QC External: BFS/Rommelag OEM technical support, calibration providers, regulatory auditors Section 4: KNOWLEDGE & EXPERIENCEMinimum Qualifications: Bachelor's degree in Mechanical, Mechatronics, or Industrial Engineering (mandatory — diploma-only profiles will not be considered) Language Skills: English (good) Years of Experience: 3+ years of hands-on BFS (Blow-Fill-Seal) machine experience — Rommelag experience strongly preferred Nature of Experience: Hands-on operation, troubleshooting, and maintenance of BFS lines exclusively within pharmaceutical manufacturing under GMP conditions. Experience from non-pharmaceutical industries (food, beverage, cosmetics, plastics manufacturing, etc.) will not be considered.???? MANDATORY ELIGIBILITY — Please read before applying: ✅ Candidate must currently reside inside Saudi Arabia ✅ Candidate must hold a transferable Iqama (قابلة للنقل) ✅ Pharmaceutical industry BFS experience only — applications from other industries will not be reviewed

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حول www.jobshubeg.com
السعودية, جدة
تصنيع الأدوية والعمليات