Technical Project Manager

3 weeks ago

Norwood, United States firstPRO, Inc Full time

firstPRO is now accepting resumes for an LMS Technical Project Manager in Norwood, MA. This is a direct hire role and onsite 2 days per week.

The Labvantage LIMS Sr. Technical Project Manager will report to and work closely with the Director, Digital LIMS Systems to ensure the implementation of new solutions and improvement of existing systems (LabVantage) for the Moderna Digital Laboratory Systems organization. This role will help shape and deliver the long-term strategic vision for the Quality Control Digital roadmap. This opportunity is unique in the pace and speed we expect and achieve and will be operating from MA


Here’s What You’ll Do

  • 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
  • Assists in evaluation or product enhancements and capabilities, implementing upgrades as required.
  • Support initial and routine upgrade system risk assessment and testing activities


Here’s What You’ll Need (Minimum Qualifications)

  • A bachelor’s degree in STEM or another relevant academic discipline required.
  • A 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


Here’s What You’ll Bring to the Table (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)

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