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.
# 102921
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