Scientist, Validation & Investigations

Biopharma Careers; Boudry; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Bristol Myers Squibb in Boudry, Switzerland, is seeking a Validation & Investigations Scientist to support the site's manufacturing units by executing validation and investigation activities with robust scientific principles. The role partners with Engineering, Technical Services, Manufacturing, QC and QA to ensure qualified systems and validated processes, while contributing to cGxP compliance and continuous improvement across MS&T.

Fluency in French and English is required.

Qualifikationen

• Requires a degree in Engineering, Chemistry, Pharmacy or Natural Science.
• Minimum 3 years of experience in pharmaceutical operations, validation, packaging, quality or related field, ideally in Oral Solid Dosage manufacturing.
• Solid knowledge of current international regulatory regulations, cGxP requirements and best practices.
• Experience in Health Authority inspections is a nice to have.
• Fluent in French and English.

Aufgaben

• Author validation and qualification documentation, including plans, protocols, reports, traceability matrices and summary reports, in accordance with approved strategies, procedures and regulatory requirements.
• 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, ensuring qualified, validated and maintained systems and processes.
• Perform 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.
• Lead and conduct investigations with appropriate methodology until conclusion and ensure reporting, root cause analysis and CAPA execution are completed.
• Prepare data-driven, risk-based impact assessments of deviations and provide reporting.
• Complete regulatory, site and department training; participate in audits/inspections as SME; contribute to continuous improvement and risk assessments.

Kenntnisse

Strong communication

Technical writing

Multilingual: French/English

Cross-functional collaboration

Analytical thinking

Ausbildung

Degree in Engineering, Chemistry, Pharmacy or Natural Science

Jobbeschreibung

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.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1606086 : Scientist, Validation & Investigations