MSAT Cleaning Validation Expert

☞ Global Life Science Jobs

看过: 125

更新日: 07-11-2025

位置: Verviers Liège

类别: 执行管理 生产/工艺

行业: Staffing Recruiting

水平: Entry level

工作类型: Full-time

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工作内容

Job Title:MSAT Cleaning Validation ExpertLocation: Verviers, BelgiumContract: 7MHours: 40 H P/WSalary: 55 EUR per hour- Umbrella/FreelancePlease note: this role does not offer any VISA sponsorship, to be eligible for the role you must have the right to work in Belgium without restriction.i-pharm consulting is working with a global pharmaceutical company with significant expertise in cell and gene therapy manufacturing, in the heart of Europe. They support several commercial autologous cell therapy products and implement mRNA / LNP as a technology on site, to serve their customers. We are looking for a MSAT Cleaning validation expert to join them at their site in Verviers, Belgium and you must be able to speak both French and English fluently.The MSAT Cleaning Validation Expert holds a critical Subject Matter Expert role within the organization, leveraging extensive expertise in various domains including process validation, manufacturing technologies, analytical testing, and product knowledge. This role is pivotal in leading process validation and driving improvements within the manufacturing processes. The incumbent will provide technical support for investigations and root cause analyses, contributing to the overall quality and compliance of the manufacturing operations.Key ResponsibilitiesLead Cleaning Process Validation:
  • Take charge of cleaning process validation projects from initiation to completion.
  • Execute validation tasks with meticulous attention to detail and scientific rigor.
  • Develop and maintain validation documentation that is clear, well-founded, and aligned with regulatory standards including European GMP, ISO13485, and 21CFR820.
  • Ensure that validation activities encompass a comprehensive approach to process verification.
Drive Cleaning Process Improvement
  • Spearhead projects focused on enhancing the cleaning process.
  • Formulate and present improvement proposals grounded in scientific rationale.
  • Conduct in-depth analyses of process parameter data to identify areas for enhancement.
  • Collaborate with cross-functional teams to implement improvements that elevate efficiency and product quality.
Planning And Budgeting
  • Develop comprehensive project plans that outline key milestones, tasks, and timelines.
  • Provide accurate evaluations of the budget required for each project.
  • Ensure alignment of project plans with organizational goals and resource availability.
Technical Expertise In Investigations
  • Leverage specialized knowledge to support technical investigations into deviations, anomalies, and incidents.
  • Collaborate with multidisciplinary teams to explore potential root causes and contribute to problem-solving efforts.
  • Design and oversee experiments to demonstrate the underlying causes of issues, enabling effective corrective and preventive actions.
Qualifications And Skills
  • Bachelor’s or master’s degree in a relevant scientific or engineering field. A Ph.D. is a plus.
  • Extensive experience in pharmaceutical, biotechnology, or medical device industries, focusing on process validation, manufacturing technologies, and analytical testing.
  • Thorough understanding of regulatory standards, including European GMP, ISO13485, and 21CFR820.
  • Proficiency in statistical analysis and data interpretation.
If you are interested in finding out more about this role or others, please contact Manpreet Bhullar at mbhullar@i-pharmconsulting.com or call UK: +44 (0)20 7551 0802 / NL: +31 20 809 0665.
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最后期限: 22-12-2025

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