Principal Scientist, Validation (R1556048-en-us)
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.
Independently performs Validation document generation and execution activities.
- Interface with Engineering, Validation, and end user groups as a subject matter expert to provide technical guidance with validation including, but not limited to, Process Performance Qualification, Continued Process Verification, Media Fill Simulation, Room / Facility Qualification, Visual Inspection Qualification, Continual Improvement Projects, Cleaning Validation, and Validation of Single Use Systems.
- Design the qualification approach, provide the scientific rationale and acceptance criteria, generate and approve validation protocols.
- Conduct, and assist others, in industry and regulatory research including research into industry standards/FDA guidelines for validation processes and make determinations regarding acceptance criteria and testing.
- Perform protocol execution and validation activities, including collection of samples associated with qualification or ongoing monitoring activities.
- Perform complex data analysis, and write protocol summaries, reports, and technical reports.
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.
- Own department programs and SOPs, and generate revisions as required based on current industry standards and regulatory requirements.
- Write and process change controls, assess impact to validated processes.
- Coordinate and lead other Validation Scientists in the work group and provide technical expertise related to validation approaches, rationales, and provide technical expertise related to process validation.
Lead teams, manage complex projects and validation programs.
- Design, implement, and maintain validation programs related to Process Performance Qualification, Continued Process Verification, Media Fill Simulation, Room / Facility Qualification, Visual Inspection Qualification, Continual Improvement Projects, Cleaning Validation, and Validation of Single Use Systems.
- Manage projects and lead specific project teams (and multiple projects), coordinate the execution of projects, prepare project schedules, and provide presentations to senior management / stakeholders on project status. Manage timelines, resources, and communications specific to individual tasks.
Independently execute departmental activities.
- Lead validation exception investigations associated with validation activities.
- Execute CAPA plans, risk programs and assessments, investigations, and root cause analyses.
- Interact and collaborate with departments (on and offsite) as well as vendors, consultants, and other external service providers.
- Demonstrate intermediate understanding of site quality GxP systems supporting document management, change controls, deviations, CAPAs.
- Train and mentor less experienced department personnel.
Perform general administrative and organizational activities.
- Conduct periodic safety inspections of Validation labs and office areas.
- Complete regulatory, site, and department training requirements on a timely basis.
Perform other tasks as assigned.
Qualifications & Experience
- High School Diploma or equivalent required.
- Bachelor’s degree preferred, preferably in Science or Engineering.
- 7 years relevant work experience required, preferably in a regulated environment.
- 5 years validation experience in a pharmaceutical or related manufacturing environment preferred.
- An equivalent combination of education, experience, and training may substitute.
- Advanced knowledge of Validation concepts and requirements.
- Advanced written and verbal communication skills.
- Detailed knowledge and interpretation of cGMP.
- Advanced critical reasoning and decision-making skills.
- Detailed knowledge of Validation industry and regulatory requirements; defend validation programs, processes, and protocols in internal and external audits.
- Ability to work independently, lead, and participate in a team.
- Intermediate project management skills.
- Intermediate proficiency in Microsoft Word, Outlook, Excel, PowerPoint, and Project.
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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