Job Title: LIMS/MODA Lab Systems Administrator
Hybrid
OBJECTIVES/PURPOSE:
Execute administration and maintenance activities in Lab Systems (e.g. LabWare LIMS, MODA) in support of the Massachusetts Biologics Operations (MBO) site
Maintain master data and workflows and assist with interfacing with instruments and other systems
Provide support to the end users at MBO and coordinate with Global system owners on system changes and communications
Manage changes and requests in the IT ticketing / change system (e.g. Service Now)
ACCOUNTABILITIES:
Maintain and update the workflows in the lab systems
Assist with system and instrument integrations, making configuration changes and coordinating with Global DD&T function as needed
Perform master data updates to support routine business changes and improvements
Support and resolve master data issues and perform routine administrative activities
Create and maintain method verification scripts and system documentation to support new functionality developments and routine updates
Provide first tier application support for routine issues, including end user questions and assistance resolving usage issues
Support validation activities for ongoing projects as needed
Perform configuration to interface instruments with the lab systems
CORE ELEMENTS RELATED TO THIS ROLE:
This role ensures that QC personnel are able to perform their operations in the lab systems at MBO in compliance with regulations, as well as global and local requirements and standards.
DIMENSIONS AND ASPECTS:
Possess extensive knowledge of the Labware LIMS and MODA systems and strong understanding of the processes they support.
Rely upon a strong understanding of the systems and processes when making decisions to determine whether process changes will have an impact on Data Integrity or the validated state of the lab systems.
Collaborate and engage with the business / personnel in the labs.
Represent MBO s interests with the Global LIMS and MODA teams and act as liason between Global and MBO site functions,
Coordinate with vendors where necessary.
Support regulatory inspections as a subject matter expert.
Interact with lab personnel to ensure shared understanding of actual system use and make recommendations for improvements to the process or system configuration.
Feel comfortable managing the activities associated with multiple workstreams, act as an SME and technical team member in lab systems related projects.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Bachelor s degree in Engineering, Computer Science, Business, Chemistry, Biology, or related discipline
3-5 years pharmaceutical or biopharmaceutical industry experience
Extensive configuration / development experience with Labware LIMS or MODA
ADDITIONAL INFORMATION:
Travel may be required for business meetings with company peers, vendors, contractors, and professional development.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.