Cleaning Validation Expert; m​/f​/d

Hiring Manager:
Violaine Villatte de Peufeilhoux

Recruiter:
Kata Kulcsar

Location:

Aubonne | Zone Industrielle de L'Ouriettaz

Department: HC-GM-BAUGK MSAT Cleaning Validation

Grade:
Expert 2 ou Expert 1 dépendant du profil

As a member of the “Cleaning Validation” group within the Manufacturing Sciences and Technologies (MSAT) team, you will be involved in activities related to the validation of Biotechnological cleaning processes (Drug Substance and Drug Product).

The cleaning process validation activity is performed in collaboration with various site teams (Production, Quality, Engineering, …) and covers the definition of cleaning validation strategies, monitoring of validation runs, data compilation, analysis of results obtained, investigations, and drafting of validation documentation. It also includes monitoring of cleaning processes and, if needed, the development of cleaning processes.

• Define validation strategies, in collaboration with the project lead and other site departments, for New Product Introductions (NPIs), Technology Transfer (TT), cleaning process validations, or changes affecting commercial products.
• Bring the required level of expertise to the project team by identifying risks, potential optimizations, the most relevant technical choices, and operational constraints.
• Develop cleaning processes as needed to ensure proper execution of the validation.
• Coordinate on‑site cleaning validations in collaboration with the affected departments.
• Ensure timely preparation of required documents (plans, protocols, and reports, risk analyses, etc.) as defined in the project plan.
• Train production teams on validation protocols.
• Supervise and support the execution of validation protocols, including outside standard working hours if necessary.
• Ensure proper documentation and data management using the relevant information systems, including quality management software.
• Compile data / collect data from production.
• Interpret the results obtained within the framework of cleaning process validation trials.
• Manage deviations and validation investigations in the appropriate system.
• Manage the monitoring of cleaning processes (drafting forms, planning, execution, drafting reports).
• Keep validation procedures and standards up to date and optimize them according to requirements and evolving current standards.
• Actively participate in a culture of integrity and professional ethics.
• Ensure compliance with legal and regulatory requirements and company directives.

• Master of Science in Biotechnology / Life Sciences / (Bio)
  Chemistry or equivalent degree, or at least 5 years of professional experience in biotechnology
• Demonstrated experience in Cleaning validation.
• Strong analytical and synthesis capabilities
• Excellent writing skills
• Proficiency with GMP/GDP and good knowledge of health authority requirements
• Organized, persistent, and resilient
• Collaborative mindset and ability to work well in a team, plus the ability to work independently and autonomously
• Very good communication skills
• Aptitude for digital tools
• Fluent in French and English (spoken and written)