Biotech Process Optimization Engineer

1 month ago


Singapore NO DEVIATION PTE. LTD. Full time
About No Deviation PTE. LTD.

No Deviation PTE. LTD. is a leading provider of patient-centric solutions for the pharmaceutical industry. Our expertise spans engineering consultancy, Commissioning Qualification Validation (CQV), Quality, Compliance, and Regulatory services.

Job Description:Overview

This role focuses on developing world-class engineering solutions that meet the unique challenges of biotech production. As a key member of our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.

Responsibilities
  • Support Process Engineers in characterizing new and existing products, maintaining metrology tools, and ensuring process excellence in high-volume biotech production settings.
  • Collaborate with various departments to support new product releases and continuous process improvement.
Key Tasks:
  • Assist in troubleshooting and sustaining production lines for consumables related to new product development, yield, quality, and throughput.
  • Design and execute controlled experiments to optimize processes, documenting and analyzing results.
  • Support MES ticket handling and process verification/validation activities.
  • Conduct nonconforming material analysis and investigations.
  • Recommend and implement process improvements to meet production goals across multiple operations and technologies.
  • Coordinate execution of equipment and process validation, data collection, and report summarization.
  • Maintain and update technical documentation, including technical requirements, drawings, and work instructions for engineering and consumables production lines.
Requirements:
  • Diploma or Bachelor's degree in Engineering, Sciences, or related field.
  • Experience in manufacturing within a FDA-regulated environment is advantageous.
  • Strong understanding of manufacturing processes within a regulated biotech or medical devices environment.
  • Ability to execute test plans for components, materials, systems, and processes effectively.
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
  • Experience with product & process feasibility studies, line validation, qualification, and process optimization.
  • Excellent team collaboration, interpersonal, and communication skills.
  • Strong documentation and technical report writing abilities.
  • Ability to manage stress and handle multitasking across functions effectively.
  • Proactive, innovative, and self-motivated.
Estimated Salary: $80,000 - $120,000 per annum

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