Sysmex Engineer, LIMS and Automation in Baltimore, Maryland
Find a Better Way... *...to use your skills and experience.* This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way.
...to improve the lives of others.** Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory.
...to build a promising future.** We currently have a great opportunity for a LIMS and Automation Engineer.The LIMS and Automation Engineer develops, maintains, and continually improves automated systems to support the processing of clinical laboratory samples and test data. As the local technical expert on computerized systems for a multi-site laboratory, this position is responsible for on-site data management, system interfaces, automated liquid handling systems as well as administration and customization of the LIMS. This role requires both individual-contributor and collaborative skills to build rapport with end-users and coordinate with cross functional teams.
Essential Duties and Responsibilities:
Lead and/or assist projects to evaluate, improve, implement and validate computerized systems as part of the clinical testing platform. These duties include writing protocols, reports, and compiling data and attachments into validation packages to meet regulatory/accreditation requirements according to CLIA/GCP/ISO. Ensure the integrity of data systems through trouble shooting, configuration and change management, as part of life cycle management.
Support the development and implementation of LabWare LIMS, which includes configuration and programming, system validation (GAMP), SOPs, development, end-user training and site administration.
Operational ownership of automated liquid handling systems and related software tools, including developing and programming pipetting methods, developing interfaces (LIMS), system validations, systems documentation, and ensuring successful implementation in the lab. Additional responsibilities include user training, troubleshooting, optimizing the workflows, on-going support for the end-users as well as routine maintenance.
Reformat and transfer clinical study sponsors’ data according to data transfer specifications (DTS) including associated documentation to ensure regulatory compliance.
Oversee the acquisition, operation, calibration and maintenance of laboratory equipment in accordance with the site quality system as an equipment manager.
- Strong written and oral communication skills in English
- Working knowledge of MS windows operating system
- Knowledge in Excel, VBA, SQL, Basic
- Basic understanding of molecular biology techniques, especially PCR and Flow Cytometry.
Knowledge of computerized system validations (i.e. GAMP) and industry standards/regulations on data integrity (i.e. 21 CFR part 11) Required Experience
Bachelor’s degree in biological, physical, engineering, computer science or closely related field required. Master’s degree preferred.
- 5 years relevant post-graduate (BS) experience, and at least 2 years in a regulated environment (e.g. ISO, CLIA,QSR, GC/LP or GMP).
- Experience with robotic liquid handling systems (preferably BC Biomek).
- Experience with configuring, administering, and troubleshooting LIMS (preferably LabWare).
- Biotech, pharmaceutical, lab automation providers, or clinical-laboratory experience is highly desirable.
Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of sex, sexual orientation, gender identity, color, religion, national origin, disability, protected Veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Tracking Code: 955-458
Job Location: Baltimore, Maryland, United States
Position Type: Full-Time/Regular