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. As a manufacturing engineer, you'll impart your knowledge and expertise, fostering a LEAN culture that emphasizes standardization, quality, continuous improvement, and increased throughput while creating and maintaining comprehensive documentation and records. Developing oneself and others will also be a significant impact in this role through training and auditing of processes and manufacturing personnel to ensure translation into standardized and repeatable processes. In addition, you'll lead and collaborate on cost-reduction and cross-functional projects with our engineering, development, quality assurance, product management, and service teams to strengthen our overall productivity and operational efficiency. Your contributions will be the foundation of our mission to improve our products and make the world a safer place.

Duties & 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.

Diversity & Inclusion

We believe that different perspectives and backgrounds are what make a company flourish. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, economic status, disability, age, or any other legally protected characteristics. We are proud to be an inclusive company with values grounded in equality and ethics, where we celebrate, support, and embrace diversity.

The Individual

Education/training:

• Bachelors degree in biology, biomedical engineering, or other related field
• Will consider applicants with equivalent work experience

Experience:

• 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. A working knowledge of non-adherent mammalian cell culture and expressing proteins in mammalian cell lines is a plus.
• Experience in technical writing, writing quality procedures, process procedures, or assembly instructions.

Knowledge/skills:

• 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.
• Hands on knowledge in additional ISO quality systems and cGMP manufacturing is a plus.
• 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.

WORK ENVIRONMENT: The individual's primary workplace is located in the Baltimore, MD biotechnology manufacturing facility; there are no exposures to unusual elements; possible exposure to biohazardous agents in BSL-2 laboratory

About Smiths

At Smiths 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.

About Smiths Detection

Smiths Detection is a global leader in detection and screening technologies for the protection of people and assets, supporting safety, security and freedom of movement in today's world.

Additional Information

Smiths Detection is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Equal Employment Opportunity Posters If you'd like to view a copy of the company's affirmative action plan or policy statement, please email US HR Team [redacted] .

If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail [redacted] or call toll-free . This email and phone number is created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response. Smiths Detection, Inc. participates in the Electronic Employment Verification Program.