Quality Engineer

Johnson & Johnson Johnson & Johnson · Pharma · Sassenheim, Netherlands

Quality Engineer role at Johnson & Johnson's new lentiviral vector production facility. Focuses on GMP compliance, deviation investigations, change controls, quality risk assessments, and audit support within a pharmaceutical manufacturing environment.

What you'd actually do

  1. Leading deviations and root cause investigations, ensuring timely follow-up and completion of non-conformance records.
  2. Writing and facilitating change controls to document introductions and changes in GMP production processes.
  3. Reviewing general LVV GMP documentation and delegating improvements to keep GMP compliance up-to-date.
  4. Participating in, leading and/or facilitating quality risk assessments (QRA).
  5. Coordinating, supporting, and preparing activities during internal and external audits in the role of Primary Contact, Subject Matter Expert (SME), scribe, or back-office lead.
  6. Coordinating internal batch release.

Skills

Required

  • Bachelor’s or University degree in Science or Engineering preferred.
  • 2-8 years’ experience in a biotechnology or biopharmaceutical (GMP) production environment.
  • Strong working knowledge of current Good Manufacturing Practice (cGMP) standards is essential
  • Experience with quality systems (e.g., Comet, TruVault).
  • Proficiency in Microsoft tools: Excel, Visio, SharePoint, Word, and PowerPoint.
  • Excellent communication skills in English

Nice to have

  • familiarity with Annex 1 regulations is preferred
  • additional Dutch language skills are preferred

What the JD emphasized

  • current Good Manufacturing Practice (cGMP) standards is essential