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Project Engineer Validation & Site Tech

Life Sciences
Validation and Qualification
Master
Medior (3+)
Location
Puurs-Sint-Amands, Antwerp
Work type
Consultancy
Work model
Fulltime, On-site

Our client, a leading pharmaceutical company, is seeking a professional to manage product and project lifecycles within their technical services department. The role focuses on providing end-to-end validation support and managing quality investigations to ensure seamless production and new product introductions.

Responsibilities

  • Manage the introduction and qualification of Single Use Systems (SUS) materials and filters for new products.
  • Lead cleaning validation activities, including the determination of validation approaches and execution of tests in production.
  • Execute sterilization validation projects across various techniques such as autoclave, VHP, and SIP.
  • Perform urgent quality investigations and conduct risk assessments to support site technical activities.
  • Prepare and maintain GMP documentation and master batch records for project compliance.
  • Implement technical changes and assess deviations related to manufacturing systems and materials.

Requirements

  • You have a Master’s degree in Bio-engineering, Pharmacy, Biochemistry, or Biotechnology.
  • You bring 3+ years of experience in executing validation projects and coordinating technical planning.
  • You possess a strong background in a GMP environment, specifically with risk assessment and deviation management.
  • You have expertise in validation including cleaning validation, sterilization validation, and Single Use Systems.
  • You're an organized, analytical, and proactive individual with strong technical writing and problem-solving abilities.
  • You are fluent in Dutch with a good knowledge of English.

Nice to Haves

  • Experience designing and maintaining master batch records.
  • Willingness to work in a shift system for specific project requirements.

Offer

  • Enjoy a competitive salary package with extra perks that recognize your talent.
  • Advance your career with a clear growth path, coaching, and mentoring to support you.
  • Thrive in a dynamic and supportive environment where you can truly make an impact.
  • Work when and where you perform best, ensuring an optimal work-life balance.
  • Choose a flexible transport solution, from a company car to a public transport subscription.
  • Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
  • Grow your skills with external courses and our in-house Pauwels Academy.
  • Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
  • Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.
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