LIMS Data System Engineer

Company: Millipore Corporation
Location: Saint Louis
Posted on: January 15, 2021

Job Description:

Your Role:Cherokee Quality Control in St. Louis, MO, supports manufacturing of custom products including active pharmaceutical ingredients, excipients, and raw materials used within the health care industry. This position within the GMP Quality Control department is responsible to support the development, validation, implementation and ongoing administrator support of a LIMS (Laboratory Information Management System) and other data systems. * Support the development, validation and implementation of a LIMS for a GMP laboratory.* Draft and review policy, procedures and protocols as assigned.* Author, execute, and/or review of scripts and test data associated with the validation of various software systems in the GMP laboratory.* Work in accordance with current GMPs and GAMP requirements.* Lead technical troubleshooting of data systems.* Lead process improvements to improve laboratory performance.* Prepare technical reports as assigned.* Manage project milestones for internal and external customers to ensure on quality and on time success.* Additional duties as assigned by QC Management.Physical Attributes:* Work in a chemical environment* Ability to perform tasks while wearing personal protective equipment (chemical protective clothing) for extended periods of timeWho You Are:Minimum Qualifications:* BS/BA in a related life science or computer science fieldPreferred Qualifications:* MS degree in a related life science or computer science field* Experience with the validation, implementation and maintenance of various computer software systems in a GMP laboratory* GMP experience in pharmaceutical, biopharmaceutical or similar industry* GMP administration experience in LIMS, database, and/or CDS (Chromatography Data System)* GMP experience with validation and the change control associated with validated computerized systems* Strong understanding of GMP guidance and regulations for APIs, excipients and drug products* Strong understanding of data integrity requirements, including the review of electronic audit trails* Strong technical writing, root cause analysis and scientific reasoning* Experience in lean lab practices and continuous improvement initiatives* GMP experience with ELN (Electronic Lab Notebooks)RSRMSSDL2017

Keywords: Millipore Corporation, St. Louis , LIMS Data System Engineer, Other , Saint Louis, Missouri