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Sr Engineer QA Cleaning Validation

Life Sciences
Validation and Qualification
Bachelor, Master
Expert (10+)
Location
Geel, Antwerp
Work type
Consultancy
Work model
Fulltime, Hybrid

Our client, a leading pharmaceutical organization, is seeking a senior expert to support their production and supply chain facility. This role focuses on providing quality oversight and acting as a subject matter expert for cleaning validation activities to ensure regulatory compliance and reliable supply.

Responsibilities

  • Assure that all cleaning validation related regulatory and procedural requirements are fulfilled.
  • Provide strategic input to the compliance improvement plan for cleaning validation.
  • Maintain quality oversight on cleaning validation actions within systemic compliance programs.
  • Review and approve validation documents such as SOPs, risk analyses, validation protocols, and trend reports.
  • Collaborate with MSAT and operations teams to introduce new cleaning validation concepts and methodologies.
  • Provide guidance on cGMP aspects for new projects and participate in multi-functional teams to achieve departmental objectives.

Requirements

  • You have a Master’s degree in a scientific field or equivalent experience.
  • You bring 8+ years of experience in the pharmaceutical or chemical industry.
  • You possess expert knowledge of cleaning validation compliance including EU cGMP, ICH Q7, and 21 CFR Parts 211.
  • You have experience with quality risk management approaches such as ICH Q9.
  • You're an analytical thinker with a strong quality attitude and the ability to make risk-based decisions.
  • You are fluent in English and Dutch.

Nice to Haves

  • Experience with the introduction of new cleaning validation concepts and methodologies.

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.
# 102232
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Candidates must be legally authorised to work in the EU and possess the required language skills for the job location.
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