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LIMS LabVantage Data Integrity & Production System Manager

Palm Beach, FL 33410

Posted: 01/31/2023 Employment Type: Direct Hire/Perm Job Category: LIMS Job Number: 540480 Is job remote?: No Country: United States

Job Description

LIMS LabVantage Data Integrity & Production System Manager  - (Full-time) - On-site

We have an urgent need for an on-site LIMS LabVantage Integrity & Production System Manager at a small but growing pharma company north of West Palm beach, Florida. Relocation assistance is available. This person will be responsible for maintaining cGMP software and IT systems within the laboratory and manufacturing areas and requires hands on management of the system administrators within the Data Integrity department. The expectations for this role include managing and maintaining the standards established for Data Integrity and compliance with IT systems and the IT Data Integrity program.  This includes coordinating with cross functional teams to develop applications to meet end user requirements, gathering requirements with outside vendors and end users and working with validation teams to validate a solution. The company culture is very collaborative with a strong focus on cross-training to supplement knowledge transfer for all roles. Competitive compensation, benefits and growth offered within this opportunity.

Benefits:
  • Competitive salary commensurate with experience
  • 401k company match, immediately vested
  • Generous PTO policy
  • Full Health Insurance Benefits
  • Relocation assistance available

Responsibilities:
 
  • Maintain cGMP software and IT processes within the laboratory and manufacturing areas
  • Hands on management of the system administrators within the Data Integrity department
  • Act as the product owner of the LabVantage 8 LIMS application and be responsible for maintaining IT systems within the organization that require GMP oversite
  • Manage and maintain the standards established for Data Integrity and compliance within IT systems
  • Coordinate with a cross functional team to develop applications to meet end user requirements
  • Work with vendors for development and coordinate with validation teams to validate a solution
  • Work on upcoming project of instrument integration using the SDMS and Empower modules in LabVantage vs 8.7
Requirements:
  • Bachelor’s in Computer Science, Life Science or similar
  • Knowledge of SQL is a plus;
  • Basic understanding of Java and Groovy programming (no coding required)
  • Deep understanding of LabVantage 8, Pharma Overlay
  • Strong understanding of IT Data Integrity Principles
  • Experience with various laboratory IT systems and the end user use of SoftMax Pro, Empower, UV-Vis, LabX, common lab instruments like pH meters and balances
  • Experience with the complete SDLC of IT applications
  • Experience supervising others, prioritizing effort to meet company goals
  • Knowledge of LabVantage Batch Management, Sample Monitoring/EM, Stability, AQC, LES, SDMS, Empower
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