Computer System Validation Engineer III
Job description
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
Job Summary
- Acts as a Subject Matter Expert for CSV on processes, procedures, and systems.
- Identifies and initiates areas for continuous improvement applicable to CSV processes.
- Responsible for development and execution of the Computerized System Validation (CSV) deliverables for enterprises systems, control systems, complex instruments, and validated spreadsheets within the facility.
- Responsible for development and execution of CSV deliverables through formal assessment, protocol development, testing, and reporting; providing a high degree of assurance that critical GxP computerized systems meet design criteria/specifications for intended use and perform as intended.
- Ensures adequate measures are in place to achieve and maintain GxP compliance through all lifecycle stages from inception to retirement.
- Lead efforts to generate documentation which meets regulatory and industry standard guidelines in a timely and efficient manner in a challenging and fast moving environment.
- These documents include but are not limited to; User Requirement Specifications, Functional Requirement Specifications, Validation Plans, design / configuration specifications, traceability matrix, design qualification, UAT, IOPQ protocols and summary reports, regression testing, data migration testing, supplier assessments, risk assessments, 21 CFR Part 11 assessments, as well as manage the site computerized systems inventory and overall critical GxP computer system lifecycle management; including Change Control and Periodic Review.
- Maintain awareness of current OSHA and safety programs.
Job Qualifications
- Bachelor’s degree in Science, Engineering, or Computer Science discipline preferred
- 5+ years’ experience in a GxP environment working with critical computerized system validation required
- May be required to work off-shift or weekends to support validation efforts.
- Advanced understanding of the authoring of protocols, Validation Summary Reports and associated documents.
- Advanced understanding and experience with CSV regulations and guidelines such as GDP, FDA; 21 CFR Part 11 Guidance: Scope and Application, 21 CFR 211.68, Data Integrity and Compliance with CGMP Guidance for Industry; and ISPE GAMP5.
- Advanced understanding of the Quality Management System, Change Control, and CAPA
Compensation Data
The pay range for this position is $104,000 - $136,000. Please note that salaries vary within the range based on factors but not limited to experience, skills, education and location.
About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.
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