| Requirement for Lab Systems Manager in Remote at Remote, Remote, USA |
| Email: [email protected] |
| Role : Lab Systems Manager Location : Remote Candidate must be in EST Duration : 6+ Months CTH Mode of interview : Video Visa : USC/GC Only This role will NOT be managing people, it will be overseeing and the Technical Lead for LIMS working with the Stakeholders to elicit requirements. Act as a Technical Lead and project Manager/BSA to support the implementation of new systems and processes. LIMS Systems Administration Responsible for supporting Quality & TechOps LIMS, ELN, SDMS, CMMS, CDS, and other lab systems. Oversee Managed Services Providers and vendors that support our applications. Work collaboratively with the CSV/Quality team to manage validation deliverables. Lab Systems Manager This person will not have any people reporting directly to them. Seeking candidates with strong LIMS system administration experience, such as LABVANTAGE LIMS They can lean more technical but will need some Business Analyst experience at the very least! Candidate needs strong communication and written skills, work well with others. Responsibilities: Work as an IT business/systems analyst to support R&D stakeholders. Work with stakeholders to elicit user/business requirements. Work as a technical lead to troubleshoot, configure, and implement GxP systems. Responsible for following good documentation practices and change management processes as outlined in the SOPs. Act as a Project Manager to support the implementation of new systems and processes. Responsible for supporting Quality & TechOps LIMS, ELN, SDMS, CMMS, CDS, and other lab systems. Oversee Managed Services Providers and vendors that support our applications. Work collaboratively with the CSV/Quality team to manage validation deliverables. Coordinate changes in accordance with established change control procedures. Communicate issues, technical failures, and projects status updates to direct manager. Responsible for communication strategy in respect to application management and support. (e.g., regular meetings with stakeholders, meeting minutes, weekly highlights). Responsible for following industry regulations, policies, and procedures (21 CFR Part 11, Data Integrity, GAMP 5, CSV, CSA) when implementing and supporting GxP systems. Minimum Qualifications: Computer Science, Engineering, or science background as it pertains to Biotech or Pharma companies. Excellent written and verbal communications skills. Ability to collaborate effectively in a dynamic, cross-functional matrix environment. Strong background working with GxP systems, computerized system validation (CSV), and technical documentation. Experience implementing and supporting lab systems, such as, research and lab systems. (ELN, LIMS, CMMS, and SDMS, etc.) Background in project management, system support and application life cycle management. Understanding and experience with industry regulations, policies, procedures, and best practices (e.g., GAMP 5, 21 CFR Part 11, Data Integrity, CSV, CSA, etc.) Warm Regards Avnish Naagar [email protected] SGI Inc.. Address: 20130 Lakeview Center Plaza, Suite 400, Ashburn, Virginia 20147 -- Keywords: rlang information technology green card |
| [email protected] View all |
| Wed Nov 15 20:09:00 UTC 2023 |