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Project Engineer - Site Tech Services (MDCP)

Life Sciences
Validation and Qualification
Master
Advanced (5+)
Location
Puurs-Sint-Amands, Antwerp
Work type
Consultancy
Work model
Fulltime, On-site

Our client, a leading pharmaceutical and medical device organization, is seeking a Project Engineer to provide technical, scientific, and project-driven support for manufacturing operations. The role focuses on leading technical improvements and sustaining on-market products through product change management and risk assessment activities.

Responsibilities

  • Lead project management activities including scoping, planning, and execution of technical improvement or investment projects.
  • Support root cause investigations for delivery system customer complaints and implement appropriate corrective and preventive actions.
  • Drive process and system improvements with a focus on enhancing and updating Design History Files.
  • Prepare and execute design and process changes, including impact assessments and required requalification.
  • Develop technical documentation such as protocols, reports, work instructions, and risk analyses.
  • Coordinate with operations, quality assurance, and suppliers to ensure clear communication and on-time project delivery.

Requirements

  • You have a Master’s degree or higher in Mechanical, Biomedical, Chemical, or Manufacturing Engineering.
  • You bring 3+ years of relevant experience in pharmaceutical or medical device manufacturing, technical support, or project engineering.
  • You possess strong knowledge of GMP and technical standards within a regulated manufacturing environment.
  • You have proven project management capabilities including planning, prioritization, risk control, and stakeholder engagement.
  • You are analytical, detail-oriented, and able to collaborate effectively across different functions.
  • You are fluent in English with knowledge of Dutch considered a plus.

Nice to Haves

  • Strong knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971 regarding design controls and device risk management.
  • Experience with injection molding technologies pertaining to the medical device or combination product industry.
  • Direct experience with medical device or combination product technology.

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.

Thank you for your interest. Unfortunately, job applications are not available in your region. To ensure a high-quality match for our clients and streamline the application process, we have certain regional limitations in place. We value all potential candidates and encourage you to explore opportunities with us in the future.

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