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Launch Excellence Project Engineer - Validation

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 Project Engineer to manage validation aspects for new product introductions. The role involves ensuring regulatory compliance and successful implementation across the product lifecycle, with a specific focus on assembly and packaging processes.

Responsibilities

  • Manage validation and documentation for assembly, labeling, and packaging processes for medical delivery systems.
  • Execute and document urgent quality investigations to maintain site compliance standards.
  • Perform comprehensive risk assessments and define appropriate mitigation measures for new product introductions.
  • Support the implementation of process and system changes related to site product launches.
  • Provide overall project management, including planning, coordination, issue resolution, and progress reporting.
  • Collaborate across service streams to ensure alignment with organizational goals and service standards.

Requirements

  • You have a Master's degree in Bio-engineering, Pharmacy, Biochemistry, or Biotechnology.
  • You bring 3+ years of relevant experience within a GMP environment.
  • You have experience in executing validation projects and performing risk assessment processes.
  • You possess strong planning and project coordination skills.
  • You're an organized, analytical, and quality-conscious professional with a strong technical writing style.
  • You have a perfect command of Dutch and a good knowledge of English.

Nice to Haves

  • Experience with auto-injectors or prefilled pens.
  • Willingness to work in a shift system if required for specific project phases.

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.
# 103074
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