Senior Scientist, Validation & Robustness (Fixed Term Contract : 18 months)

at  BristolMyers Squibb

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. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us .

Primary responsibilities include:

• Equipment Qualification,
• Process Performance Qualification

Your main responsibilities are:

• Independently performs in Validation, document generation, management, 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 production equipment.
• Design the validation/qualification approach, provide the scientific rationale and acceptance criteria, generate and approve validation/qualification protocols.
• Conduct, and assist others, in industry and regulatory research including research into industry standards/FDA guidelines for validation equipment / processes and make determinations regarding acceptance criteria and testing.
• Lead projects, prepare project schedules and execute validation studies, perform complex data analysis, and write protocol summaries, reports, and technical reports.
• Support or/and lead investigations associated with qualification activities.
• Own and execute projects, programs, procedures, investigations, and activities.
• Manage projects in the work group and lead specific project teams (and multiple projects), coordinate the execution of validation projects, prepare project schedules and provide presentations to senior management / stakeholders on project status.
• Manage timelines, resources, and communications specific to individual tasks.
• Execute CAPA plans, risk programs and assessments, investigations, and root cause analysis.
• Intermediate understanding of site quality GxP systems supporting document management, change controls, deviations, CAPAs.
• 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.
• Train and mentor less experienced department personnel.
• Performs general administrative and organizational activities.
• Complete regulatory, site, and department training requirements on a timely basis.
• Performs other tasks as assigned