Clean Room QA/QC Engineer

Context

As part of a major pharmaceutical construction project, the Clean Room QA/QC Engineer will be responsible for the quality supervision of clean room envelope construction and finishes in compliance with GMP standards, regulatory guidelines, and project specifications. This includes partitions, doors, ceilings, flooring, coatings, and ensuring clean room environmental integrity.

Missions & Responsibilities

• Provide technical guidance to clean room quality inspectors and subcontractors.
• Review and approve clean room-related quality documents (ITP, PQP, SQP, method statements, material approvals).
• Supervise and inspect clean room construction activities, including:
  • Partitions and wall panels(flush, sealed, compliant with GMP).
  • Ceilings(suspended, walkable, sealed systems).
  • Flooring(epoxy, vinyl, antistatic, chemical-resistant).
  • Doors, windows, pass-boxes, and clean room furniture integration.
  • Coatings, sealants, and finishesensuring smooth, cleanable surfaces.
• Ensure compliance with GMP, ISO 14644, and EU GMP Annex 1clean room requirements.
• Perform inspections and witness tests for:
  • Air tightness, smoke/pressure differential tests.
  • Surface smoothness, cleaning, and contamination control.
  • Installation quality of panels, joints, and penetrations.
• Manage and follow up QOR (Quality Observation Reports)and NCR (Non-Conformance Reports).
• Ensure full traceability and archiving of all QA/QC documentation.
• Support the Turnover teamfor clean room handover packages.
• Cooperate closely with CSA, HVAC, and Process QA/QC engineersto ensure clean room compliance.
• Provide monthly QA/QC reportsto the Construction Manager (CM) and Project Manager (PM).
• (Bonus) Experience with EIDA Toolfor inspection/test tracking is highly valued.

Profile & Requirements

• Degree in Civil, Architecture, Mechanical, or related Engineering field.
• 3–7 years of QA/QC experiencewith clean room construction in the pharmaceutical, biotech, or semiconductor sector.
• Deep knowledge of GMP requirementsand ISO 14644 clean room classification.
• Proven experience with partitions, ceilings, doors, flooring, coatings, and sealing systems.
• Understanding of air flow requirements, differential pressure, and contamination control.
• Familiarity with qualification activities(DQ/IQ/OQ support for clean rooms).
• Fluent in English(oral & written). German is a plus.
• Rigorous, detail-oriented, strong communication and reporting skills.
• Ability to work within a complex, multidisciplinary construction project.

Job Category

Cleanroom

Job Type

Construction

Job Location

Germany