Duration: 6 months
Location: Remote (EST)
Hours: 20 hours/week
Rate: $60/hour
Experience Level: 5+ years
We are seeking a Techno-Functional Specialist with strong expertise in Labware LIMS Development, GxP-compliant process awareness, and hands-on experience with ServiceNow. The ideal candidate will bridge the gap between technology and business processes, ensuring compliance, efficiency, and innovation in pharmaceutical domain solutions.
Strong experience with Labware LIMS basic programming.
Expertise in Labware LIMS visual workflows and Crystal Reports.
Oracle/SQL database queries.
Understanding of laboratory workflows in pharmaceutical environments.
Knowledge of GxP, FDA 21 CFR Part 11, and data integrity.
Experience with integration and web services (REST/SOAP).
Domain Knowledge:
Awareness of pharmaceutical industry standards, GxP compliance, and validation processes.
Experience with OnPrem, COTS, and SaaS applications in regulated environments.
Knowledge of Labvantage LIMS is a plus.
Provide ongoing support for existing LIMS applications and assist end-users by troubleshooting and resolving day-to-day issues.
Configure, customize, and maintain LIMS functionalities to align with evolving business needs and workflows.
Ensure full compliance with GxP documentation standards, including validation activities (IQ, OQ, PQ) and maintaining audit readiness.
Provide technical guidance and expertise for enhancements, upgrades, and new feature implementations within the LIMS environment.
Design, optimize, and maintain database structures and subroutines to improve performance and reliability.
Collaborate with infrastructure teams to support Disaster Recovery (DR) exercises and related operational activities.