Description

Hiring Manager: Aline JeannotRecruiter: Kata KulcsarLocation: AubonneDepartment: HC-GM-BAUGE MSAT Validation Strategy & Process Control - Process ValidationGrade: Expert 2  As a member of the Process Validation group within the MSAT (Manufacturing Sciences and Technologies) team, you will be involved in activities related to the validation of Biotechnological manufacturing processes (Drug Substance, Drug Product, and Finished Product). Process manufacturing validation activities are performed in collaboration with various site teams (Production, Quality, Engineering, Supply, etc.) and encompass defining process validation strategies, tracking validation testing, compiling data, analysing results, conducting investigations, and drafting validation documents. Your role: Define validation strategies, in collaboration with the project manager and other site departments, for New Product Introductions (NPI), Technology Transfer (TT), manufacturing process validation, or changes affecting marketed products.Bring the required level of expertise to the project team by identifying risks, potential optimizations, the most relevant technical choices, and operational constraints.Coordinate on-site process validation activities in collaboration with impacted 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 process validation protocols, including outside of standard hours if necessary.Ensure appropriate documentation and data management using the relevant computer systems, including quality management software.Compile data / Collect data from production.Interpret results obtained in the context of process validation testing.Manage deviations and validation investigations in the appropriate system.Keep validation procedures and standards up to date and optimize them according to requirements and evolving standards.Actively contribute to a culture of integrity and professional ethics.Ensure compliance with legal, regulatory, and corporate directives. Your profile: Master of Science in Biotechnology / Life Sciences / (Bio)Chemistry or equivalent degree, or at least 5 years of professional experience in biotechnologyDemonstrated experience in process validation. Strong experience in Drug Substance processes is an assetStrong analytical and synthesis capabilitiesExcellent writing skillsProficiency with GMP/GDP and good knowledge of health authority requirementsOrganized, persistent, and resilientCollaborative mindset and ability to work well in a team, plus the ability to work independently and autonomouslyVery good communication skillsAptitude for digital toolsInterest in statistical analysesFluent in French and English (spoken and written)