Principal Scientist, Validation
vor 4 Wochen
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.
The Principal Scientist is part of the “Validation & Robustness” team of MS&T Boudry department. This role is responsible for managing processes related to qualification/validation activities through the complete validation life cycle.
Primary responsibilities include:
- Process Performance Qualification
- Continued Process Verification
- Continual Improvement Projects
Serves as a Subject Matter Expert in a specific Process Validation specialty and provides expert technical recommendations/guidance. Leads large scale projects, prepares and leads project schedules/project teams, executes complex validation studies/investigations, and performs associated data analysis applying the principles of statistics and quality risk management.
Key Responsibilities:
- Site Lead for the implementation of structures, tools, and processes to actively manage process performance/robustness across the BMS Pharma portfolio.
- Contribute to ensure that new pharma products are launched with an appropriate level of robustness, in collaboration with other MS&T functions and Manufacturing site.
- Design and execute procedures that enable an efficient collection of data from the different unit operations in line with the defined control strategy.
- Perform analysis of data and draw up robustness boards.
- Lead the issuing of Continued Process Verification plans and reports.
- Independently performs and/or leads team in Validation, document generation, management, and task execution.
- Manage projects in the work group and lead specific team initiatives, coordinate the execution of validation projects, prepare project schedules and provide presentations to senior management/stakeholders on project status.
- Manage timelines, resources, and communication for specific Project or initiative.
- Execute validation studies, perform complex data analysis, and write protocol summaries, reports, and technical reports.
- Support other Validation Scientists in the work group and provide technical expertise related to validation approaches and rationales.
- Train and mentor less experienced department personnel.
- Conduct, and assist others, in industry and regulatory research including research into industry standards/FDA guidelines for processes validation and make determinations regarding acceptance criteria and testing.
- Interact and collaborate with departments (on and offsite) as well as vendors, consultants and other external service providers acting as a subject matter expert to provide technical guidance with validation.
- Design the validation/qualification approach, provide the scientific rationale and acceptance criteria, generate and approve validation/qualification protocols.
- Own department programs and SOPs, and generate revisions as required based on current industry standards and regulatory requirements.
- Lead and execute CAPA plans, risk programs and assessments, investigations, and root cause analysis associated with Qualification/Validation topics.
- Implement changes through standard change control process, assess impact to validated equipment and processes.
- Intermediate understanding of site quality GxP systems supporting document management, change controls, deviations, CAPAs.
- Performs general administrative and organizational activities.
- Complete regulatory, site, and department training requirements on a timely basis.
- Performs other tasks as assigned.
Specific Knowledge, Skills, Abilities:
- Excellent working knowledge of QA, cGMP and the Pharmaceutical Regulatory framework.
- Excellent knowledge of current qualification/validation practices.
- The ability to influence and work across organizational boundaries.
- Excellent command of English and preferably another European language.
- Strong written and verbal communication and interpersonal skills.
- Project and change management experience. Experience with Product Life Cycle Management.
- Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.).
- Self-starter, team player, effective leader and keen on working in a cross-cultural working environment.
Education/Experience/Licenses/Certifications:
- Bachelor Degree in Engineering, Chemistry, Pharmacy or Natural Science.
- Minimum 5-7 years of experience in pharmaceutical industry with MSc degree or 8-10 years’ experience with BSc in GMP validation activities are considered an asset but not mandatory.
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