Labware Consultant

Location:
Newbury Park (Thousand Oaks), CA

Duration: 8 Months

Job Summar

• yLabWare LIMS Configuration Specialist to support the Lab Ware 8 upgrad
  e for a US‑based GMP laboratory site. This role will lead a dedicated workstream focused on implement ing raw material and commercial product workflow
  s, completing master data configuratio
  n, and finalizing integration with laboratory equipment and enterprise GMP system
  s
• .The successful candidate will translate regulatory, quality, and operational requirement
  s into standardized, compliant Lab Ware LIMS designs and ensure stable execution of configured workflows in a regulated manufacturing environment

.
Key Responsibiliti

on Support a dedicated workstream supporting implementation of raw material and commercial product process
es within Lab Ware LIMS

• 8.Define and manage Lab Ware bui
  ld acros
• s:
  
  Raw materials and commercial product master da
• ws Laboratory equipment and interfac

es
Lab Ware LIMS Configurat

ion Configu
re raw materials, commercial products including stability, and laboratory equipm
ent in Lab Ware LIMS usi
ng standardized, compliant design patte
r

ns.

Ensure Lab Ware configuration aligns wi

• th:
  
  Approved test methodolog
• ies Product specificati
• ons Sampling pl

ansApp
ly controlled build practi
ces and normalized templates to ensure consistency, scalability, and complian

• ce.
  
  Requirements Traceability & Validation Supp
  ort Transl
  ate regulatory, quality, and operational requireme
  nts into standardized Lab Ware LIMS desig
• ns.
  
  Support validation activities by providing clear documentation and traceability for configured Lab Ware objects following internal procedur
• es.
  
  Instrument & System Integration :
  Configure and supp
  ort instrument interfa
  ces between Lab Ware 8 and a variety of laboratory syste
• ms.
  
  May develop or supp
  ort parsing scri
  pts, where required and permitted by Takeda standards and governan
• ce.
  
  Support connectivity and data flow between Lab Ware and oth
  er GMP syst
  ems, such as L
• abXOperational Readiness & Execut
  ionSupp
  ort stable execut
  ion of raw material and equipment workflows in live operatio
• ns.
  
  Troubleshoot configuration and integration issues impacting laboratory executi
• on.
  
  Partner with site teams to ensure Lab Ware configurations are fit for intended use and operationally sustainab

le.
Required Qualificat

• ions Proven hands‑on experience configur
  ing Lab Ware LIMS (Lab Ware 8 strongly preferr
• ed).Strong experience with Lab Ware wit
  hin GMP laboratory operat
  ions, particula
• rly:
  
  Raw materials tes
• ting Commercial product tes
• ting Laboratory equipment workf
• lows Demonstrated ability to trans
  late regulatory and quality requirem
  ents into compliant LIMS configurati
• ons.
  
  Experience support
  ing LIMS valida
  tion with full requirements traceabil
• ity.
  
  Experience integrating Lab Ware w
• ith:
  
  Instrument systems (e.g., Empower, L
• abX)
  Strong cross‑functional communication skills in regulated environme
• nts.
  
  Preferred Qualificat
  ions Experience support
  ing Lab Ware upgrades or major LIMS implement at
  i
• ons.
  
  Experience working in biopharmaceutical or pharmaceutical GMP environm
  e
• nts.
  
  Experience supporting inspection readiness activities related to L
• IMS.Deliverables & Success Crite
  ria Completed on time Lab Ware LIMS configurations for raw materials, commercial products, and equipment integrat
• ion.
  
  Clear requirements‑to‑configuration‑to‑validation traceabil
• ity.
  
  Stable, compliant execution of configured workflows in operati
• ons.
  
  Successful integration between Lab Ware and laboratory instrum

ents
Additional

• Note This role requires close collaboration with Takeda Quality, Validation, IT, and Laboratory t
• eams.
  
  Work must follow Takeda change control, validation, and data integrity requirem
• ents.
  
  Onsite presence may be required based on project phase and site n