CSV Validation QC Engineer

Since 1995, Supremesoft Corporation has been partnering with clients to strengthen their key business processes by identifying critical issues and implementing innovative customized solutions. Through the years, Supremesoft has grown steadily into a global information technology consulting company, by establishing and building a solid reputation on dedicated technology practices with a highly experienced workforce. Today, many of our existing clients turn to us as their sole trusted partner for technical expertise.

Position

Description:

Mandatory

Skills:

• 7+ years of Lab Systems (& lab instrumentation) validation experience is required; with 7+ years of other CSV experience (with extensive experience authoring requirement specs, test scripts, validation master plans, etc)
• Prefer a degree in the sciences (chemistry, biology, biochem, etc)
• 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 a must
• Excellent communication and written skills are required.

Preferred

Skills:

• Experience in Labware, Empower LIMS systems
• Experience in validating Lab equipment

Job Role s/Responsibilities:

• 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.

All your information will be kept confidential according to EEO guidelines.