CSV Validation QC Engineer

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 must
• Excellent communication and written skills are required.

Preferred Skills

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

Job Roles/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.