Scientist, Validation and Robustness - Boudry, Schweiz - Bristol Myers Squibb

Bristol Myers Squibb

Geprüftes Unternehmen

Boudry, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

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
Coordinate 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.