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.
The Principal Scientist is part of Validation & Robustness team of MS&T Boudry department. This role is responsible for managing processes related qualification/validation activities through the complete validation life cycle.
Primary responsibilities include:
- Process Performance Qualification,
- Continued Process Verification,
- Continual Improvement Projects.
- 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 ( 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.
- 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.
- 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 and in GMP validation activities are considered an asset but not mandatory**.**
**Uniquely Interesting Work, Life-changing Careers**
**On-site Protocol**
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model wit
-
Principal Scientist, Qualification Lead, Validation
vor 6 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**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...
-
Senior Validation Scientist
vor 1 Woche
Boudry District, Schweiz Bristol-Myers Squibb VollzeitTransforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled Principal Scientist, Validation to join our team in Boudry, Switzerland.The successful candidate will be responsible for managing processes related to...
-
Principal Scientist – Technology Transfer
vor 3 Wochen
Boudry District, Schweiz Bristol-Myers Squibb VollzeitTransforming Patients' Lives through ScienceBristol-Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients overcome life-threatening diseases. We are seeking a highly skilled Principal Scientist – Technology Transfer to join our team in this exciting role.Job...
-
Principal Scientist
vor 5 Monaten
Boudry, Schweiz Bristol Myers Squibb Vollzeit**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...
-
Principal Scientist
vor 5 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**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...
-
Principal Scientist, Analytical Network Investigator
vor 4 Monaten
Boudry, Schweiz Bristol Myers Squibb VollzeitBei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu...
-
Principal Scientist, Analytical Network Investigator
vor 4 Monaten
Boudry, Schweiz Bristol Myers Squibb Vollzeit**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...
-
Principal Scientist Exm
vor 5 Monaten
Boudry, Schweiz Bristol Myers Squibb VollzeitBei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu...
-
Principal Scientist Exm
vor 5 Monaten
Boudry, Schweiz Bristol Myers Squibb Vollzeit**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...
-
Principal Scientist Stability
vor 5 Monaten
Boudry, Schweiz Interiman Vollzeit**INTRODUCTION**: For our client, a leading international Pharmaceutical company, we are searching for a: **Principal Scientist Stability - 100% - 12 months temporary contract** **English & French** This position is responsible for stability product strategy and oversight of product stability programs for commercial small molecules Drug Substances and Drug...
-
Principal Scientist, Packaging
vor 5 Monaten
Boudry, Schweiz Bristol Myers Squibb VollzeitBei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu...
-
Principal Scientist, Packaging
vor 5 Monaten
Boudry, Schweiz Bristol Myers Squibb Vollzeit**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...
-
Ingénieur de validation mécanique
vor 2 Wochen
Boudry District, Schweiz EURHASI VollzeitMissionL'objectif principal de ce poste est de garantir la qualité et la fiabilité des systèmes d'assemblage développés par EURHASI. Vous serez chargé de la validation de ces systèmes, en identifiant les problèmes techniques et en proposant des solutions pour les résoudre.Vous travaillerez en étroite collaboration avec les équipes de...
-
Ingénieur Validation Systèmes
vor 3 Wochen
Boudry District, Schweiz Gi Group SA VollzeitÀ propos de l'emploiNous recherchons un Ingénieur Validation pour rejoindre notre équipe dynamique et innovante.Activités PrincipalesIdentifier les problèmes techniques, rechercher des solutions et communiquer efficacement avec les équipes de projet.Agir comme point de contact central entre les partenaires externes et l'équipe interne de...
-
Ingénieur de validation mécanique
vor 3 Wochen
Boudry District, Schweiz EURHASI VollzeitMissionL'objectif principal de ce poste est de garantir la qualité et la fiabilité des systèmes d'assemblage développés par EURHASI. Vous serez chargé de la validation de ces systèmes, en identifiant les problèmes techniques et en proposant des solutions pour améliorer leur performance.Vous travaillerez en étroite collaboration avec les...
-
Principal Scientist Ms&t Ds Exm
vor 5 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**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...
-
Ingénieur Validation
vor 2 Monaten
Boudry District, Schweiz Gi Group SA VollzeitÀ propos de notre PartenaireNotre partenaire, leader mondial des solutions d'automatisation avancées, recherche un ingénieur Validation pour rejoindre son équipe dynamique et innovante.Vos Activités PrincipalesEn tant qu'Ingénieur Validation, vous serez au cœur de la validation de nos systèmes d'assemblage, en veillant à atteindre les objectifs...
-
Scientist, Lead Investigator
vor 1 Woche
Boudry, Schweiz Hobson Prior International Ltd VollzeitHobson Prior is seeking a Scientist, Lead Investigator for a contract role in Boudry, Switzerland. This position focuses on technical operations and quality control within the engineering and warehouse sectors. Please note that to be considered for this role you must have the right to work in this location. Responsibilities: Help manage and assess...
-
Ingénieur de validation mécanique
vor 1 Woche
Boudry District, Schweiz EURHASI VollzeitMissionL'objectif principal de ce poste est de garantir la conformité des systèmes d'assemblage à nos exigences de qualité. Vous serez responsable de la validation de nos systèmes d'assemblage, en identifiant les problèmes techniques et en proposant des solutions. Vous travaillerez en étroite collaboration avec les équipes de projet pour...
-
Stability Principle Scientist
vor 4 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**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...
