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Lab Systems Validation Analyst
Ref No.: 18-58525
Location: Wilson, North Carolina
Position Type:Contract
Start Date: 08/14/2018
Job title: Lab Systems Validation Analyst
Location: Wilson, NC/ Elkton, VA
Job Type: CWR / CTH
Rate: $65/hr

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 hands-on 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 equipments

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.