Labvantage LIMS Technical Project Manager

2 weeks ago


Cambridge, Massachusetts, United States Moderna Full time
Job Title: Senior Technical Project Manager for LabVantage LIMS

The Senior Technical Project Manager for LabVantage LIMS will play a critical role in ensuring the successful implementation of new solutions and improvement of existing systems for the Moderna Digital Laboratory Systems organization.

Key Responsibilities:
  • Lead projects to improve functional, technical, configuration, and development for the Digital landscape supporting the QC laboratories
  • Act as the Technical Project Manager for the LabVantage LIMS integration with external systems
  • Manage fast-phase projects and deliver results as expected
  • Provide leadership and architectural knowledge within large cross-functional projects
  • Propose, lead, and deploy small and medium-size continuous improvement projects within the Lab Systems
  • Independently deliver projects and initiatives in a timely and qualitative manner
  • Highlight potential risks and act proactively to resolve issues
  • Participate in the demand management process to assist the business in establishing business cases relating to new systems or potential system changes
  • Work independently to author System Configuration Specification, System Administration SOP, execute test scripts following cGxP
  • Author, review, and approve lifecycle documents like Impact assessment, Regulatory applicability, and criticality assessments, ERES assessments, etc.
  • Work with the Lab Automation team to interface the standalone systems with LIMS
  • Assist in evaluation or product enhancements and capabilities, implementing upgrades as required
  • Support initial and routine upgrade system risk assessment and testing activities
Requirements:
  • Bachelor's degree in STEM or another relevant academic discipline required
  • Minimum 10 years of industry experience implementing and maintaining laboratory systems
  • Must have 5+ years of experience working with LabVantage LIMS and Application Integration
  • Must have experience working with Instrument integration to LabVantage LIMS
  • Experience authoring and reviewing computer system validation lifecycle documents
  • Working understanding of cGMP and manufacturing operations and practices
  • Strong communication skills (verbal and written)
  • Demonstrated ability to work independently and collaboratively in cross-functional teams
  • Compliance-focused mindset
Preferred Qualifications:
  • Working understanding of cGMP and manufacturing operations and practices
  • An understanding of computer systems validation practices (GAMP)
  • Strong communication skills (verbal and written)
  • Demonstrated ability to work independently and collaboratively on cross-functional teams
  • Experience working in a matrixed environment
  • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at (EEO/AAP Employer)



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