Validation Manager

16 hours ago

Ljubljana, Ljubljana, Slovenia HW3 Full time €90,000 - €120,000 per year

Do you have proven experience managing CQV projects within large-scale pharmaceutical environments?

Are you confident in leading clean utility project delivery, ensuring full compliance with GMP standards?

Do you thrive in managing teams of CQV leads across multiple systems in complex drug substance facilities?

We are seeking a highly experienced
CQV Manager
to support a major drug substance manufacturing programme on a long-term assignment. The successful candidate will oversee clean utility and process system CQV delivery, ensuring alignment with project objectives, regulatory requirements, and corporate standards.

Key Responsibilities:

  • Act as overall CQV Manager for clean utility systems (water, gases, E&I, process utilities) and laboratory support systems.
  • Ensure planning, execution, and documentation of commissioning and qualification activities in line with GMP.
  • Oversee schedule, budget, resources, and stakeholder alignment.
  • Coordinate with engineering, validation, and operations teams to ensure seamless project integration.
  • Drive issue resolution, risk management, and continuous improvement across CQV activities.
  • Report project status and performance to senior leadership.

Requirements:

  • 10+ years' experience within pharmaceutical CQV project delivery.
  • Strong background in clean utilities.
  • Understanding of water systems, gas distribution, E&I, process utilities, and laboratory systems.
  • Proven experience in drug substance facilities.
  • Track record of managing and mentoring CQV teams.
  • Excellent communication and stakeholder management skills.

This is an outstanding opportunity for a seasoned CQV Manager to lead mission-critical projects in a state-of-the-art pharmaceutical facility, shaping the successful delivery of complex utilities and drug substance manufacturing systems.

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