LIMS(Laboratory Information Management System) Architect : Remote(Local to PA Preferred)

 

 

Looking for LIMS/SME Architect with experience in LIMS, Software Development Life Cycle (SDLC), LES, ELN, Requirements Analysis, Enterprise Software Management, and Software Documentation.

Should have worked in Green field and Brown field implementations

Should have experience building strategy, apply functional and technical expertise to manage solutions and customer s business needs and requirements.

Experience in Leading LIMS implementations in Pharma, BioPharma, for QA/QC/microbiological Labs (please update relevant areas)

Facilitates and negotiates with Sr. Mgmt./C-level to ensure understanding of project & program strategy and ensure delivery of agreed scope Collaborate with leadership team to align business requirements with LIMS features. Enforce configuration to implement GxP, CLIA, 21CFR Part 11 and HIPAA requirements.

Strong analytical, problem solving and troubleshooting skills.

Knowledge of Sample workflows, stock module, instrument module, Instrument Interfacing using Integration Manager, Report Designer, Forms Designer, Label Designer, Sample Scheduler, Batch Management, Lot management and Plate handling, stability, SQC, SM-IDI, PIMS modules in Sample Manager LIMS.

Collaboration with Software Architect(s) and other technical groups (Includes design, documentation, prototyping and validation)

Facilitate the definition of scope/objectives involving relevant stakeholders and ensuring technical feasibility