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Equipment Reliability Specialist

2 weeks ago

Singapore beBeeProduction Full time $120,000 - $180,000

Job Description:

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This role ensures Drug Product (DP) and Drug Substance (DS) process equipment for commercial scale manufacturing operations performs optimally for long-term manufacturing success.

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The key responsibilities include troubleshooting technical challenges, driving innovative solutions to enhance production efficiency and equipment reliability, while maintaining compliance with industry regulations and GMP standards.

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During project execution, the Production Equipment Engineer is a critical contributor to the design, installation, commissioning, and qualification of process equipment for large-scale biopharmaceutical projects.

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Operational Phase Responsibilities:

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  • Oversee and improve ongoing maintenance and operational reliability of DP and DS process equipment.">
  • Implement asset management systems to track maintenance schedules, spare parts, and costs.">
  • Ensure all equipment requiring statutory inspections are scheduled and tracked in CMMS systems.">
  • Train maintenance teams on new procedures, troubleshooting, and safety protocols.">
  • Set up and maintain a maintenance workshop equipped with necessary tools and procedures.">
  • Regularly review maintenance data to identify areas for process improvement and cost reduction.">
  • Establish protocols for handling downtime, emergency maintenance, and system failures promptly.">
  • Support continuous improvement initiatives and implement design enhancements based on operational feedback.">
  • Maintain strict compliance with GMP standards and safety regulations, ensuring no significant findings during inspections.">
  • Facilitate the transition from project completion to full operational status, ensuring a seamless handover.">
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Project Phase Responsibilities:

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  • Provide technical expertise during the design phase to ensure equipment meets all operational requirements.">
  • Collaborate with design team and vendors to establish maintenance strategies, spares availability, and service contracts.">
  • Develop and maintain engineering documentation.">
  • Support technical evaluation during procurement stage by reviewing equipment data sheets and technical requirements.">
  • Lead the development of bidding documents, vendor evaluations, and bidding processes.">
  • Participate in key commissioning activities including system checks, lubrication, alignment, and performance testing.">
  • Troubleshoot and resolve commissioning issues and discrepancies.">
  • Support or execute qualification tests and inspections according to approved protocols.">
  • Document qualification results and deviations, and ensure compliance with validation requirements.">
  • Review qualification reports and support final approval processes.">
  • Conduct technical inspections to support handover, ensuring system functionality and compliance.">
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Requirements:

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  • Bachelor degree in mechanical engineering, mechatronics or related field.">
  • Minimum 8 years of experience in process equipment engineering within biopharmaceutical, pharmaceutical, or biotech manufacturing.">
  • Hands-on experience with bioreactors, chromatography skids, ultrafiltration systems, CIP skids, DP filling lines, Lyophilizers, automated visual inspection machines and other DP/DS process equipment is highly desirable.">
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Professional Requirements:

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  • Strong understanding of GMP, biopharmaceutical manufacturing processes, and equipment validation.">
  • Experience managing multiple priorities and delivering high-quality results within tight deadlines.">
  • Mechanical and production equipment experiences in Biotech or production with understanding of mechanical principles, components, and systems related to production equipment.">
  • Familiar with computerized maintenance system (e.g. Maximo or others).">
  • Ability to diagnose equipment malfunctions, analyze root causes of failures, implement corrective actions, and optimize equipment performance through continuous improvement initiatives.">
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Other Special Requirements:

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  • Proficient in office productivity tools, AutoCAD, and other relevant engineering software used for design, documentation, and analysis.">
  • Exhibit self-initiative, independence, and a goal-oriented mindset, taking ownership of tasks from design through to operational readiness.">
  • Possess strong collaboration and communication skills, with ability to work effectively across teams.">
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