Scientist, Validation and Robustness
Vor 7 Tagen
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.
**Position Summary**
The Validation & Robustness Scientist is supporting the development and implementation of strategies that ensure Global Commercial Supply is maintained in a constant state of compliance for the good of our patients. More specifically, the Validation & Robustness Scientist partners with other MS&T functions to design and execute procedures that guarantee the manufacturing robustness at internal and external sites.
**Skills/Knowledge Required**
- Degree in Engineering, Chemistry, Pharmacy or Natural Science.
- Minimum 5 years of experience in pharmaceutical industry and in GMP validation activities are considered an asset but not mandatory.
- Ability to work well as part of a large Project Team.
- Ability to work across organizational boundaries.
- Good written and verbal communication and interpersonal skills.
- Good command of English and preferably another European language.
**Duties and Responsibilities**
- Lead/Support 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 (possibly in real time) 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.
- May be assigned Subject Matter Expert (SME) role for a defined validation/qualification area
- Ensure equipment, systems and processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle
- Prepare protocols and reports that enable execution of experiments or Technical Batches.
- Lead / support the completion of investigations led by Boudry MS&T by issuing documents or reports.
- Interface with multiple sites and departments (i.e., Engineering, Facilities, Manufacturing, Regulatory Affairs, Quality Control and Quality Assurance) and suppliers to accomplish predefined goals.
- Support the development of project plans for validation and qualification activities and ensure results are delivered in a timely manner.
- Author and when required review validation documents, including but not limited to validation plans, protocols, reports, traceability matrices and summary reports.
- Execute validations / qualifications for equipment and systems across the site
- Lead risk assessments and risk management teams
- Review change controls and maintenance interventions, evaluating the impact upon qualified systems & validated processes, and documents required actions
- Manage validation projects; including managing time, resources and budgets; own associated change controls
- Co-ordinate qualification and validation execution activities, including external vendors and internal departments
- Maintain procedures governing validation to ensure they are in compliance with corporate policies and regulatory requirements
- 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
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.
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