Senior CQV Engineer - Clean Utilities Specialist

Optimus Life Sciences; Wien; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Optimus Life Sciences in Vienna is seeking an experienced Senior CQV Engineer specializing in Clean Utilities to join a major long-term manufacturing and expansion programme.

You will lead CQV activities across GMP utility systems, support design review, commissioning and qualification of clean steam, HVAC interfaces, and develop DQ/IQ/OQ/PQ documentation while collaborating with QA, Validation and external vendors.

Qualifikationen

• Strong background in pharmaceutical/biotech sterile manufacturing.
• Proven CQV/validation track record for GMP clean utility systems.
• Experience with WFI, PW, Clean Steam and process gas infra.
• Experience on capital projects, expansions, upgrades or new facility builds.
• GMP knowledge including FDA, EMA and ISPE standards.

Aufgaben

• Lead CQV activities across GMP utility systems.
• Review URS documents, engineering drawings, P&IDs and risk assessments.
• Develop and execute DQ, IQ, OQ and PQ documentation.
• Review URS and regulatory documentation and support CAPA investigations.
• Collaborate with Engineering, QA, Validation, Manufacturing and external vendors.
• Drive continuous improvement and optimisation of clean utility systems.

Kenntnisse

CQV/Validation

GMP knowledge

Clean Steam

Process Gas

Capital Projects

Autonomous Work

Jobbeschreibung

Optimus Life Sciences in Vienna is seeking an experienced Senior CQV Engineer specializing in Clean Utilities to join a major long-term manufacturing and expansion programme.

You will lead CQV activities across GMP utility systems, support design review, commissioning and qualification of clean steam, HVAC interfaces, and develop DQ/IQ/OQ/PQ documentation while collaborating with QA, Validation and external vendors.