Validation & Investigations Scientist — Elevate Process Robustness

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

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.