Sterility Process Engineering Expert

Posted One Month Ago
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Antwerpen, BEL
In-Office
Senior level
Professional Services • Biotech • Consulting • Pharmaceutical
The Role
Support clients to achieve Annex 1 sterile manufacturing compliance by providing hands-on expertise in isolators, RABS, cleanroom design and qualification, aseptic techniques, process validation, contamination control (CSS plans), and environmental monitoring programs.
Summary Generated by Built In
🔍 Sterility Process Engineering Expert

📍 Location: Flanders
🕓 Type: Full-time

🏢 What you’ll be doing

Join our new Annex 1 solution experts and support clients in achieving compliance with updated sterile manufacturing requirements. You'll bring hands-on expertise in isolators, RABS, cleanroom qualification, and contamination control.

💡 What’s in it for you?

Make a real impact: Contribute to shaping the future of the Life Sciences industry by supporting innovative projects and clients across pharma, biotech and medical devices

Grow within a community of experts: Benefit from knowledge-sharing, mentoring, and exposure to diverse, challenging assignments that broaden your expertise.

Build a meaningful career: As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.

A fair, competitive package: We offer tailored, transparent compensation aligned with your expertise, preferences, and local market regulations — because your contribution deserves to be valued.

💪 What you bring
  • Senior experience in sterile manufacturing environments

  • Proven isolator/RABS qualification experience

  • Knowledge of cleanroom design and qualification

  • Expertise in aseptic techniques and process validation

  • Deep understanding of contamination control strategies (CSS plan) and Annex 1 requirements

  • Experience with environmental monitoring (EM) programs

🫵 Who you are
  • You're a sterile manufacturing specialist who understands the critical nature of this work

  • You combine technical rigor with practical problem-solving

  • You stay current with regulatory changes (Annex 1, PIC/S)

  • You're quality-focused and comfortable working in high-stakes environments

✨ About us

We support life sciences companies from idea to patient — offering tailored solutions in development, clinical, regulatory, compliance, production, and distribution. With 500+ experts across 8 countries, we help drive innovation in ATMP, biotech, medical devices, diagnostics, digital health, and pharma.

We believe in JPEG:
Joy. Partnership. Going the Extra Mile. Getting Things Done.

You won’t just be taking a job — you’ll be joining a community where people grow, laugh, build, and contribute to something bigger.

📩 Interested? Let’s talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family.

Skills Required

  • Senior experience in sterile manufacturing environments
  • Proven isolator/RABS qualification experience
  • Knowledge of cleanroom design and qualification
  • Expertise in aseptic techniques and process validation
  • Deep understanding of contamination control strategies (CSS plan) and Annex 1 requirements
  • Experience with environmental monitoring (EM) programs
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The Company
HQ: Wilrijk
700 Employees
Year Founded: 2011

What We Do

QbD Group is an international life sciences consultancy supporting companies from idea to patient. It provides tailored solutions across development, clinical services, regulatory affairs, quality and compliance, production, distribution, and related software. The company serves advanced therapies, biotech, medical devices, diagnostics, digital health, and pharmaceutical organizations, helping clients accelerate innovation, achieve regulatory compliance, and grow with operational confidence across global markets.

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