Empower Integration Engineer (Labvantage)

ProPharma GroupRaleigh, NC
Hybrid

About The Position

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Requirements

  • LabVantage integration experience
  • Empower project structure configuration
  • Method configuration and documentation
  • Template adoption and decision documentation
  • Report Method validation
  • Empower Verification IVI execution in ALM
  • Legacy project maintenance

Responsibilities

  • Initiate and obtain approval for a site change control to support LabVantage (LV) integration with Empower.
  • Define, configure, and document the Empower project structure, including one (1) parent project per method to enable policy mapping and controlled access.
  • Create, configure, and baseline go-live and verification projects, including required templates and access controls.
  • Update methods within the site Master Project in accordance with approved standards; verify method settings and document completion.
  • Review Global Empower-provided base Sample Set Method and Processing Method templates; align peak names, rename Sample Set Methods using the “TMP_” prefix, and document template adoption decisions.
  • Update and validate Report Methods, as applicable, to support LV-enabled workflows and reporting requirements.
  • At go-live, execute the Empower Verification IVI in ALM; confirm successful completion, expand method project access to all lab groups per SOP, and copy approved/finalized methods from the Master Project into the new method projects.
  • Post go-live, migrate remaining methods into the new project structure; perform legacy project maintenance activities; and document completion and outstanding issues, as applicable.

Benefits

  • Diversity, equity, and inclusion initiatives
  • Encouragement of innovative, collaborative, and entrepreneurial spirits
  • Safe space for employees to succeed
  • Personal review of all applications by a recruitment team member
  • Outcome provided for all applications
  • Support for remote working
  • Encouragement of hybrid work for those within commuting distance of an office
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