Sr Specialist, Scientist, Validation
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.
Purpose and Scope of Position
The Validation Scientist is responsible for developing qualification approaches (risk/science based) and provide the supporting scientific rationale. Will perform independent execution of validation protocols, data analysis, summary and technical reports with minimal oversight.
Required Competencies: Knowledge, Skills, and Abilities
- Intermediate understanding of Validation concepts and requirements.
- Intermediate knowledge of cGMP.
- Intermediate written and verbal communication skills
- Ability to work independently, and within a team.
- Intermediate proficiency in Microsoft Word, Outlook, Excel, Project, Visio, and PowerPoint.
- Intermediate knowledge of Validation industry and regulatory requirements.
- Advanced knowledge of cGMP
Duties and Responsibilities
- Independently performs Validation document generation and execution activities.
- Generate and execute validation protocols, and assist other department members in conducting industry and regulatory research.
- Operate instrumentation; perform protocol execution and validation activities, including collection of samples associated with qualification.
- In coordination with Production and Validation management, schedule equipment times, prepare test equipment and assure that testing is completed according to approved validation protocols.
- Conduct training for internal customers on protocols associated with validated equipment, systems, processes, and specifications.
- Perform data analysis, including the use of statistics, and prepare written reports/summaries from validation studies.
- Perform Validation exception investigations associated with qualification activities as required.
- Cross check and verify validation data prepared by others during the regular peer review process
- Participate in and own protocols, projects, and activities Execute qualification activities with limited oversight
- Participate in project teams, while managing timelines, resources and communications specific to individual tasks.
- Generate project schedules and manage qualification activities according to site objectives and timelines.
- Collaborate with applicable departments to ensure activities are completed as scheduled.
- Edit department SOPs; generate revisions as required.
- Execute CAPA plans, risk assessments, investigations, and root cause analysis.
- Basic understanding of site quality systems (Oracle, eQRMS, CelDox). Defend validation protocols in internal and external audits with limited oversight.
- Interact and collaborate with departments (on and offsite) as well as vendors, consultants and other external service providers. Performs general administrative and organizational activities.
- Completes and files required documentation as applicable.
- Conducts periodic safety inspections of Validation labs and office areas.
- Completes regulatory, site, and department training requirements on a timely basis.
- Performs other tasks as assigned
Education and Experience
- High school diploma or equivalent required
- Bachelor’s degree preferred, preferably in Science or Engineering.
- 4 years’ relevant work experience required, preferably in a regulated environment.
- 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 email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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