Validation Consultant

☞ PSC Biotech Corporation

Ver: 140

Día de actualización: 16-11-2025

Ubicación: Liège City Liège

Categoría: Seguro de Calidad / Control de Calidad

Industria: Biotechnology Research

Posición: Associate

Tipo de empleo: Full-time

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Contenido de trabajo

About PSC Biotech Ltd

Who we are?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Essential Functions

  • Identifying validation/qualification requirements
  • Taking part/facilitating/recording process risk analysis and cross contamination assessment
  • Facility qualification activities (planning, documenting, analyzing data, reporting)
  • Equipment qualification activities (planning, documenting, analyzing data, reporting)
  • Process validation activities (planning, documenting, analyzing data, reporting)
  • Product validation activities (planning, documenting, analyzing data, reporting)
  • Raw materials validation activities (planning, documenting, analyzing data, reporting)
  • Perform validation of excel files
  • Review and approve thermo mapping reports
  • Take part in the improvement of validation and equipment management system (write, review and approve procedures, forms, etc.)
  • Take part in the documentary management related to equipment
  • Take part in the change control management related to equipment
  • Arranging and supervising third party services required for validation activities when applicable

Requirements

  • Language: English must (writing and reading), French a strong advantage
  • 3-5 years of experience
  • Strong understanding and experience on facility/equipment/process/cleaning validation requirements under EN ISO 13485 / Regulation (EU) 2017/746 and 21 CFR 820
  • Strong documentation skills
  • Understanding of molecular diagnostics (PCR)
  • Ability to understand manufacturing lines functionalities and their validations (e.g validation of machine vision)
  • Experience on risk management (especially process FMEA)
  • Experience on Hologic validation procedures is desirable but not essential
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Plazo: 31-12-2025

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