We are seeking a dedicated Process Engineer, Aseptic Production to step in as the Technical Owner for our production Line 1 in aseptic manufacturing. In this pivotal role, you will ensure the stable, GMP-compliant operation of the line throughout its entire lifecycle. This position requires deep technical equipment and process expertise to drive sustainable troubleshooting, optimize equipment availability, and lead technical projects while acting as the primary spokesperson for the line across internal and external stakeholders.
Your responsibilities will include,
- Act as the primary technical subject matter expert (SME) and Technical Owner for Line 1.
- Maintain and build a comprehensive understanding of equipment mechanics, automation (PLC/SCADA), utility supplies (WFI, HVAC), and aseptic filling processes.
- Define, evaluate, and refine preventive and predictive maintenance strategies to maximize line performance and OEE (Overall Equipment Effectiveness).
- Lead complex problem-solving initiatives and moderate root cause analyses (e.g., 5-Why, Fishbone, FMEA) for recurring or complex equipment malfunctions.
- Drive technical contributions and sustainable resolutions for Deviations (DRs) and CAPAs.
- Systematically track malfunction data and conduct Pareto and OEE analyses to drive targeted improvements in efficiency and process stability.
- Lead technical improvement projects, including equipment modifications, GMP optimizations, and the introduction of new formats and products (Tech Transfers).
- Ensure strict adherence to GMP compliance (specifically Annex 1) and take responsibility for maintaining the qualified state of the equipment.
- Create, maintain, and review SOPs, technical instructions, risk analyses, and Change Controls, acting as the technical expert during audits and inspections.
- Act as the primary technical spokesperson for Line 1 in interactions with clients, regulatory authorities, and cross-functional teams (Production, QA, MSAT, Engineering).
- Manage critical components, spare parts strategies, and coordinate shutdown planning closely with Technical Service.
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