Lead Engineer, CSV

Overview

Lead Engineer, CSV role at Bristol Myers Squibb .

The Lead Computer System Validation (CSV) Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent contributes to the completion of milestones associated with equipment qualification and systems validation. With minimal supervision and given general instructions, this individual performs routine tasks, applies basic analytical skills to solve common problems, and collaborates with the immediate supervisor and team to achieve goals while building trust and cross-functional relationships.

Shifts Available Monday to Friday, 8 a.m. to 5 p.m.

Responsibilities

• Supports equipment qualification and validation activities.
• Investigates and resolves Deviations, CAPA investigations, and other potential issues.
• Configures and documents the configuration of computerized systems to meet the requirements of 21 CFR Part 11.
• Supports the execution of equipment qualification and validation protocols.
• Supervises vendors for qualification functions.
• Completes qualification and validation documentation with accuracy, completeness, and compliance to BMS standards.
• Owns lifecycle deliverables in equipment qualification and full CSV for single and multi-user computerized systems.
• Develops validation / qualification deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, and Change Controls.
• Initiates, manages, and leads projects of moderate scope within the functional area.
• Maintains positive relationships with team members and customers, promoting a collaborative learning environment.
• Authors quality procedures and training documents; delivers training on procedures and best practice to relevant audiences.
• Innovates and develops tools and solutions to improve efficiency and compliance.
• Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turnover to the business area.
• Supports standardization efforts in the review and approval of validation deliverables.
• Provides excellent customer service and support; regularly reviews and responds to qualification and support requests.
• Interfaces with customers to ensure expectations are met; ensures equipment, facilities and programs are maintained in compliance.

Knowledge & Skills

Basic Requirements

Working Conditions

Compensation

The starting compensation for this job is a range from $86,490 - $104,800 , plus incentive cash and stock opportunities (based on eligibility). Final, individual compensation will be decided based on demonstrated experience.

Eligibility for benefits varies by job and location. For more on benefits, please visit the careers site.

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