Biotech Process Optimization Engineer
1 month ago
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:OverviewThis 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.
- 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.
- 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.
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