Bristol Myers Squibb
Manager, Computer System Validation, Cell Therapy
Bristol Myers Squibb, Summit, New Jersey, us, 07902
Manager, Computer System Validation, Cell Therapy
Working with Us: Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. The Manager, CSV Cell Therapy supports the successful implementation and support of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses strong analytical skills to recognize and solve common problems of various degrees of complexity and scope. RESPONSIBILITIES: Maintains all qualified and validated equipment and systems in compliance with policies, guidelines, and procedures. Supports equipment qualification and validation activities. Configures and documents the configuration of computerized systems to meet the requirements of CFR21 Part 11. Supports the execution of equipment qualifications and validation protocols. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry. Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance. Strong working knowledge of SDLC principles and standards. Ability to work with the end user to identify and document User and Functional Requirements. Education and Experience: BS degree or equivalent experience. Minimum 5 years of experience in FDA-regulated industry. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
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Working with Us: Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. The Manager, CSV Cell Therapy supports the successful implementation and support of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses strong analytical skills to recognize and solve common problems of various degrees of complexity and scope. RESPONSIBILITIES: Maintains all qualified and validated equipment and systems in compliance with policies, guidelines, and procedures. Supports equipment qualification and validation activities. Configures and documents the configuration of computerized systems to meet the requirements of CFR21 Part 11. Supports the execution of equipment qualifications and validation protocols. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry. Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance. Strong working knowledge of SDLC principles and standards. Ability to work with the end user to identify and document User and Functional Requirements. Education and Experience: BS degree or equivalent experience. Minimum 5 years of experience in FDA-regulated industry. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
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