Manufacturing Engineer

4 weeks ago

Baltimore, Maryland, United States Smiths Detection Full time
Job Description

The Biotechnology Manufacturing Engineer will lead the manufacturing and continuous improvement of our cell culture-based biosensors and pathogen detection reagents. In this role, the individual will also be responsible for corrective and preventative actions related to manufacturing non-conformances and issues to maintaining high quality.

Key Responsibilities
  • Investigate and solve manufacturing issues related to biological detection products as they occur; implement corrective and preventative actions.
  • Champion LEAN culture and continuous improvement initiatives. Supports CI events to ensure that improvements are captured, implemented and sustained.
  • Create and maintain manufacturing job test procedures, work instructions, and master process documents.
  • Design manufacturing fixtures and prototypes as required.
  • Develop process and test protocols for automated equipment and manual processes.
  • Establish and maintain routings, control BOM changes, and maintain BOM configuration dates.
  • Maintain master material data for all manufactured products.
  • Drive cost reduction projects to meet requirements of Value Engineering initiatives.
  • Perform validation testing on new products and changes to existing products.
  • Primary liaison with Development and Engineering teams on new products and engineering issues.
  • Responsible for seeing that engineering changes are validated and implemented in manufacturing.
  • Lead continuous improvement of cell culture-based production of biosensors for uniform performance and cost reductions
  • Develop and implement quality standards and perform QC tests for biosensors and other reagents
  • Develop and conduct reagent stability studies and validations
  • Lead material requirements planning and inventory management for all biosensor-related parts.
  • Drive cell banking production process for all current and new biosensor cell lines.
  • Maintain all site equipment certifications and preventative maintenances
  • Develop, improve, and implement cGMP practices in biotechnology lab settings
  • Complies with and ensures department compliance with all Company, policies and procedures.
Requirements
  • Bachelor's degree in biology, biomedical engineering, or other related field
  • 2-5 years related experience in a discreet manufacturing environment - ideally with extensive hands-on experience in cell culture including working with adherent and non-adherent mammalian cell lines, preparing master and working banks, and with cryopreservation techniques.
  • Experience in technical writing, writing quality procedures, process procedures, or assembly instructions.
  • Advanced computer skills including Excel, Microsoft Word and Outlook; SAP or equivalent is preferred; CAD-based systems and bioinformatics is a plus.
  • Hands-on experience with ISO 9001 and Lean Manufacturing.
  • Working knowledge of cell biology, molecular biology and immunology.
  • Working knowledge of basic microbiology techniques and ability to work with BSL-2 level pathogens.
  • Ability to design experiments, interpret data, and prepare final reports.
  • Ability to troubleshoot protocols and procedures.
  • Team player and possesses a strong capability to work independently.
  • Strong verbal and written communication skills.
  • Ability to gain the trust and respect of your team members.
  • Good organizational skills and attention to detail.
About Smiths Detection

At Smiths Detection, we apply leading-edge technology to design, manufacture and deliver market-leading innovative solutions that meet our customers' evolving needs, and touch the lives of millions of people every day. We are a FTSE100, global business of around 14,600 colleagues, based in 50 countries. Our solutions have a real impact on lives across the planet, enabling industry, improving healthcare, enhancing security, advancing connectivity and supporting new homes. Our products and services are often critical to our customers' operations, while our proprietary technology and high service levels help create competitive advantage. We welcome colleagues with a curious mind, who are happy with responsibility, enjoy a challenge and are attracted by the idea of working at a business with an almost 170 year history of innovation, and five global divisions, all experts in their field.

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