Scientist, Validation & Investigations Full-time

Scientist, Validation & Investigations

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

MS&T is a science-driven organization dedicated to building in-depth and comprehensive knowledge of our products and their processes. We work across the entire lifecycle of our Pharmaceutical Products and support the Boudry internal manufacturing site.

The Validation & Investigations Scientist is supporting the Boudry manufacturing process units by executing investigation and/or validation activities within MS&T using established scientific principles, contributing to product quality, process robustness, and cGxP compliance.

Acts in one or more domain among Equipment Qualification, Cleaning Validation, Process Validation, Robustness and Investigations.

More specifically, the Validation & Investigations Scientist partners with other site and MS&T functions to design and execute procedures that guarantee the robustness of manufacturing processes at internal sites.

Duties/Responsibilities

Validation, Qualification & Robustness

• Author validation and qualification documentation, including but not limited to plans, protocols, reports, traceability matrices and summary reports, in accordance with approved strategies, procedures and regulatory requirements. These documents may be in relation with equipment qualification, process validation, cleaning validation, continued process verification. The designed approaches must include scientific rationales and acceptance criteria, and be based on quality risk management principles.
• Execute validation, qualification, or robustness activities across the site, including data collection and data analysis.
• Support introduction of new products or new technologies on the site, by ensuring associated equipment, systems and processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
• Perform the assessment of change controls and maintenance interventions, evaluating potential impact to qualified systems and validated processes.
• Interface with Engineering, Technical Services, Manufacturing, QC, QA and other stakeholders to support MS&T objectives.

Investigations

• Support initial assessments of deviations in order to assist deviation owners to define need for investigations.
• Lead and conduct investigations with appropriate methodology until conclusion and ensures that the investigation outcome, root cause analysis and execution of corrective and preventive actions are completed in a timely, effective and compliance manner. Investigation scope may be related to bulk operations, packaging operations, warehouse, or maintenance processes.
• Prepare data-driven, scientifically justified, risk-based impact assessment of deviations in order to support their classification, in conjunction with Quality Operations
• Provide appropriate level of reporting and communication on the assigned investigations.

General

• Complete all required regulatory, site and department training in a timely manner.
• Participate in audits and inspections as a supporting Subject Matter Expert, when required.
• Contribute to continuous improvement, including proactively identifying problems, gathering inputs from operational teams and proposing solutions
• Contribute to risk assessments as Subject Matter Expert
• Provide support to other MS&T projects as required.
• May be involved in additional projects/initiatives at site or global level to represent Boudry MS&T Team (EHS, continuous improvement, quality, risk management, etc)

Reporting Relationship

This position reports to the Associate Director of Validation & Investigations Boudry MS&T.

Qualifications

Specific Knowledge, Skills, Abilities:

• Ability to constructively work across functional areas and levels.
• Strong communication skills
• Technical writing skills
• Fluent in French and English
• Capability to work with short deadlines and simultaneous activities
• Strong analytical, problem solving skills

Education/Experience/ Licenses/Certifications:

• Degree in Engineering, Chemistry, Pharmacy or Natural Science.
• Minimum 3 years of experience in pharmaceutical operations, validation, packaging, quality or related field, if possible in Oral Solid Dosage manufacturing.
• Solid knowledge of current international regulatory regulations, cGxP requirements and best practices
• Experience in Health Authority inspections (preparation, process, presentations, responses drafting, etc.) is a nice to have.