Job Description

Responsible for manufacturing engineering activities related to all biological products, corrective and preventative actions related to manufacturing non-conformances / issues, documentation, cost reduction, interface with engineering, development, quality, product management, and service, and training of manufacturing personnel. Supports LEAN culture focusing on standardization, quality, improved performance and increased throughput.

Job duties to include but are not limited to;

• Managing high-throughput, large scale cell culture expansions
• Develop, maintain and improve processes and test protocols for biosensor and finished goods manufacturing which comply with cGMP practices.
• Create and maintain manufacturing job test procedures, work instructions, and master process documents.
• Maintain master material data in SAP for all biological products, including component product data, bills of materials and production routings.
• Determine reagent and inventory needs to maintain cell culture operations
• Primary liaison with Development and Engineering teams on new products and engineering issues. This includes but is not limited to performing validation testing on new and updated products and processes and implementing these changes in production
• Develop, improve, and implement cGMP practices in biotechnology lab settings
• Perform root cause analysis (RCCA) for issues related to biological products and implement effective corrective and preventive actions..
• Complies with and ensures department compliance with all Company, policies and procedures.

Qualifications

Education: BS Biological Engineering, equivalent experience in lieu of degree considered

Experience:

• 2-5 years of 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.

Technical Knowledge, Skills and Abilities:

• 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-2level 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.

SDI is a Federal Contractor and a drug-free workplace. By submitting an application, I confirm that I understand that the Company has a right to require me to submit to a drug test prior to employment and at any time during my employment, to the extent permitted by law.

This position requires Sensitive Security Information (SSI) access and vetting via the TSA. Applicant must successfully pass a federal background investigation.

Additional Information

The compensation for this position ranges from $51,192 - 119,449yrand will vary depending on factors such as your location, skills, job-related knowledge, and experience. The compensation package may also include incentive compensation opportunities in the form of discretionary annual bonus or commissions. Smiths Detection provides comprehensive benefits including healthcare, 401K savings plan, company holidays, vacation, sick time, parental leave and an employee assistance program. Eligibility requirements apply.

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 hr-1@smiths-detection.com.

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 stat@smiths.com or call toll-free 877-703-1029. 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.

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.

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.

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, colour, 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.

At no time during the hiring process will Smiths Group, nor any of our recruitment partners ever request payment to enable participation – including, but not limited to, interviews or testing. Avoid fraudulent requests by applying jobs directly through our career’s website (Careers - Smiths Group plc)