Lead Engineer, CSV
Welcome to Bristol-Myers Squibb, a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines to patients with serious diseases. We are seeking a highly motivated Lead Engineer, CSV to join our team and drive excellence in computer system validation (CSV) across our organization. If you are passionate about ensuring the quality and compliance of computerized systems in a highly regulated environment, this could be the perfect opportunity for you. As the Lead Engineer, you will play a critical role in maintaining the integrity of our data and systems, ultimately contributing to the development and delivery of life-changing therapies. We are looking for a detail-oriented and collaborative individual with a strong understanding of CSV principles and experience in the pharmaceutical industry. If you are ready to make a difference in the lives of patients and drive the success of our company, we encourage you to apply for this exciting position.
- Develop and implement computer system validation (CSV) strategies and procedures to ensure compliance with regulatory requirements.
- Lead and oversee the entire CSV lifecycle, including planning, execution, and documentation.
- Collaborate cross-functionally with various departments, including IT, Quality Assurance, and Regulatory Affairs, to ensure CSV activities are aligned with company goals.
- Stay up-to-date with industry regulations and best practices related to CSV and implement necessary changes to maintain compliance.
- Conduct risk assessments and develop risk mitigation plans for computerized systems.
- Manage a team of CSV engineers, providing guidance, support, and training as needed.
- Conduct regular audits and reviews of computer systems to identify any potential issues and implement corrective actions.
- Develop and maintain relationships with external vendors and contractors to ensure the quality and compliance of their systems.
- Collaborate with project teams to ensure CSV requirements are integrated into system design and development.
- Develop and maintain documentation, including validation plans, protocols, and reports, to support the CSV process.
- Participate in regulatory inspections and audits, providing necessary documentation and evidence to demonstrate compliance.
- Identify and implement process improvements to enhance the efficiency and effectiveness of the CSV process.
- Act as a subject matter expert on CSV principles and provide guidance and support to other team members.
- Communicate regularly with management and stakeholders to provide updates on the status of CSV activities and any potential risks or issues.
- Continuously evaluate and improve the quality and compliance of computerized systems to ensure the safety and efficacy of our products.
Extensive Experience In Computer System Validation (Csv): A Lead Engineer At Bristol-Myers Squibb Must Have A Deep Understanding Of Csv Principles, Guidelines, And Industry Best Practices. They Should Have A Proven Track Record Of Successfully Leading And Executing Csv Projects In A Highly Regulated Environment.
Strong Technical Background: The Ideal Candidate For This Role Should Possess A Strong Technical Background In Computer Science, Engineering, Or A Related Field. They Should Have A Thorough Knowledge Of Software Development Life Cycle, Programming Languages, Databases, And Data Management Systems.
Project Management Skills: As A Lead Engineer At Bristol-Myers Squibb, The Candidate Will Be Responsible For Leading And Managing Csv Projects From Initiation To Completion. Therefore, They Should Have Excellent Project Management Skills, Including Planning, Organizing, And Resource Allocation.
Regulatory Compliance Knowledge: Bristol-Myers Squibb Is A Highly Regulated Company, Operating In The Pharmaceutical Industry. Hence, The Lead Engineer Must Have A Thorough Understanding Of Regulatory Requirements, Such As Fda And Gxp Guidelines, And Be Able To Ensure Compliance Throughout The Csv Process.
Leadership And Communication Skills: This Role Requires The Candidate To Work Closely With Cross-Functional Teams, Including Engineers, Quality Assurance, And Regulatory Personnel. The Lead Engineer Must Possess Strong Leadership And Communication Skills To Effectively Collaborate And Communicate With Team Members And Stakeholders At All Levels Of The Organization.
Quality Assurance
Process Improvement
Project Management
Data Analysis
Technical Writing
Change control
Risk assessment
Protocol Development
Test Execution
Validation Planning
Gxp Compliance
Communication
Conflict Resolution
Leadership
Multitasking
Time management
creativity
Teamwork
Adaptability
Problem-Solving
Empathy
According to JobzMall, the average salary range for a Lead Engineer, CSV in 768 County Rte 512, Summit, NJ 07901, USA is between $120,000 and $160,000 per year. This may vary depending on the specific company, industry, and level of experience of the individual. Additional factors such as bonuses, benefits, and location can also impact the salary range. It is recommended to research the specific company and industry to get a more accurate estimate of the salary for this role.
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Bristol-Myers Squibb Co. operates as a biopharmaceutical company, which engages in the discovery, development, licensing, manufacturing, marketing, distribution, and sale of biopharmaceutical products. It includes chemically-synthesized drugs or small molecules and products produced from biological processes called biologics.
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