Principal Scientist, Computer System Validation

bristolmyerssquibb
Phoenix, US Full Time
POSTED ON 5/22/2022 CLOSED ON 11/18/2022

What are the responsibilities and job description for the Principal Scientist, Computer System Validation position at bristolmyerssquibb?

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Position Summary Independent contributor responsible for performing computerized systems validation activities through the validation life cycle. Primary responsibilities include qualification of process automation, laboratory instruments, databases, and IT infrastructure, technical writing and execution. Serves as a subject matter expert in GxP computerized systems and provides expert technical recommendations and compliance guidance for engineering, IT, and other technical groups. Leads validation projects, executes and manages system qualification, and implements industry best practices for the design and delivery of GxP computerized systems. Key Responsibilities Interface with Engineering, Validation, and end user groups as a subject matter expert to provide technical guidance with validation including, but not limited to, design and requirements development, software testing, system administration, data management, and risk management. Lead projects, prepare project schedules and execute validation studies, perform data analysis, and write protocol summaries, reports, and technical reports. Perform protocol execution and validation activities, including collection of data associated with qualification or ongoing support activities. Coordinate with business process owners and other groups as needed to execute routine testing and validation on GxP computerized systems. Conduct training for internal customers on protocols associated with validated equipment, systems, processes, and specifications. Contribute to the design, implementation, and management of site programs related to periodic reviews, data governance, system administration, risk management, and software development. Support development or revisions of SOPs as required based on current industry standards and regulatory requirements. Execute CAPA plans, risk assessments, investigations, and root cause analyses. Working understanding of site quality GxP systems supporting document management, change controls, deviations, CAPAs. Independently track own work and deliverables, with regular reporting to management. Interact and collaborate with departments (on and offsite) as well as vendors, consultants and other external service providers. Write and process change controls, assess impact to validated equipment, utilities, facilities, and processes. Coordinate and lead other Validation Scientists in the work group and provide technical expertise related to validation approaches. Qualifications & Experience Advanced knowledge of MS office applications Intermediate knowledge of Windows operating systems and laboratory specific applications Intermediate knowledge of IT Networking, Virtual server technology, backup and recovery, system security, as it relates to computer validation Intermediate knowledge of Software Design Life Cycle validation Intermediate knowledge of Computer Software Assurance "CSA" Intermediate knowledge of cGMP, GXP, GAMP Advanced written and verbal communication skills Advanced organizational and time management skills Advanced teamwork and facilitation skills Requires strategic thinking and ability to work independently Ability to interpret /write technical documents Interact and collaborate with departments (on and offsite) as well as vendors, and consultants Write and process change controls, assess impact to validated equipment, utilities, facilities, Education and Experience Bachelor’s degree required, preferably in Science or Engineering. 5 years validation experience in a pharmaceutical or related manufacturing environment preferred. An equivalent combination of education, experience and training may substitute. Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 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. Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture. To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S. Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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