Lab Systems Validation Analyst

Description

Mandatory Skills 7+ years of Lab Systems CSV experience is required; or 5+ years as user of Lab Systems with 7+ years of other CSV experience
Specific handson experience with validating, qualifying, and/or using Pharmaceutical GMP QC Lab Standalone COTS systems are required
Experience working with systems users from different sites is required. Experience with international sites is highly desired.
Pharma industry experience is must
Excellent communication and written skills are required
Preferred Skills Experience in Labware, Empower LIMS systems
Experience in validating Lab equipment
Job Role Act as Validation and Qualification Lead on a large global GMP QC Laboratory remediation projects, with specific focus on Laboratory Standalone COTS systems
Author the typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.
Assist systems users with defining and documenting system use in user, admin, and maintenance SOPs
Coordinate alignment of systems users from various company sites, including international sites, on validation and qualification documentation
Proactively communicate with various company organizations and systems vendors to ensure the project hurdles are overcome quickly and effectively
Provide tactical guidance and coaching in support of systems testing efforts
Act as validation task lead take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc.