Principal Scientist, Qualification Lead, Validation
vor 7 Monaten
**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.
The Principal Scientist, Qualification Lead, Validation & Robustness, is responsible for managing process related qualification/validation activities through the complete validation life cycle.
Primary responsibilities include:
- Equipment Qualification,
- Process Performance Qualification,
- Continued Process Verification,
- Continual Improvement Projects and Cleaning Validation.
Key Responsibilities
- Independently performs and/or leads team in Validation, document generation, management, and execution activities.
- 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.
- Lead validation exception investigations associated with qualification activities.
- Perform Validation exception investigations associated with qualification activities.
- Own and execute complex projects, programs, procedures, investigations, and activities.
- Design, implement, and maintain validation programs related to equipment validation, including but not limited to equipment vendor selection.
- 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.
- Own department programs and SOPs, and generate revisions as required based on current industry standards and regulatory requirements.
- 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.
- Responsible for driving the commissioning and qualification activities of several equipment at Boudry with external partners according to Bristol Myers Squibb standards and regulatory requirements.
- Effectively manages assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.
- Interface with multiple sites and departments (Engineering, Technical Services, MS&T, end user groups, QA, suppliers, Architectural / Engineering Contractor, Construction Management contractor, Asset Care Management contractor, and C&Q contractor) to accomplish predefined goals and to provide technical guidance including but not limited to production OSD equipment.
- Design and author the validation/qualification approach (plan), provide the scientific rationale and acceptance criteria, generate and review/approve commissioning, validation/qualification protocols/reports.
- 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.
- Provide presentations to team members in multidisciplinary meetings and also to senior management / stakeholders on project status.
- Lead/support the completion of complex investigations, initiate change controls (incl. assessing impact of the change) and managing corrective action plans associated with C&Q activities
- Participate when required during internal and external audits for which they are a SME, by answering questions, reviewing qualifications and validations with auditors, and providing documentation
- 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 and rationales.
- Train and mentor less experienced department personnel.
- Performs general administrative and organizational activities.
- Complete regulato
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