CQV Manager

QP Group; Berlin; Vor Ort; EUR 80.000 - 110.000; Vollzeit

Zusammenfassung

QP Group in Germany is seeking a hands-on CQV Manager to lead Commissioning, Qualification and Validation activities across our pharmaceutical manufacturing operations. This execution-focused role requires you to drive CQV and CSV deliverables on the ground, safeguarding project milestones and site readiness.

You will develop IQ/OQ/PQ protocols, master plans, and reports, collaborating closely with Engineering, Quality, and Manufacturing to align validation timelines with client programs.

Qualifikationen

• Proven experience in CQV and CSV within a CDMO, pharmaceutical, biotech, or GMP-regulated manufacturing environment.

Aufgaben

• Lead and execute Commissioning, Qualification, and Validation (CQV) activities across equipment, systems, and facilities
• Drive Computer System Validation (CSV) processes in line with GxP and regulatory requirements
• Develop and manage validation protocols, master plans, and reports (IQ/OQ/PQ)
• Partner cross-functionally with Engineering, Quality, and Manufacturing teams to ensure validation timelines align with client project milestones
• Support audit and inspection readiness through robust documentation and compliance practices, including client and regulatory audits
• Identify and troubleshoot validation issues, driving resolution in a fast‑paced, hands‑on capacity
• Build toward future ownership of CAPEX project management as site capital projects scale

Kenntnisse

Hands-on mindset

GxP knowledge

FDA regulations

IQ/OQ/PQ execution

Cross-functional communication

CAPEX project interest

Stakeholder management

Jobbeschreibung

We're working with a growing CDMO (Contract Development and Manufacturing Organization) to find a hands‑on CQV Manager to lead Commissioning, Qualification, and Validation (CQV) activities across their manufacturing operations.

About the Role

This is a genuinely execution-focused role - you won't just be overseeing from a distance, you'll be directly driving CQV and CSV deliverables on the ground. For the right candidate, there's a clear path to grow into a CAPEX Project Manager role as the site's capital project pipeline expands.

Responsibilities

• Lead and execute Commissioning, Qualification, and Validation (CQV) activities across equipment, systems, and facilities
• Drive Computer System Validation (CSV) processes in line with GxP and regulatory requirements
• Develop and manage validation protocols, master plans, and reports (IQ/OQ/PQ)
• Partner cross-functionally with Engineering, Quality, and Manufacturing teams to ensure validation timelines align with client project milestones
• Support audit and inspection readiness through robust documentation and compliance practices, including client and regulatory audits
• Identify and troubleshoot validation issues, driving resolution in a fast‑paced, hands‑on capacity
• Build toward future ownership of CAPEX project management as site capital projects scale

Qualifications

• Proven experience in CQV and CSV within a CDMO, pharmaceutical, biotech, or GMP‑regulated manufacturing environment

Required Skills

• Hands‑on operational mindset — comfortable executing, not just managing from a distance
• Strong working knowledge of GxP, FDA, and relevant regulatory validation requirements
• Experience with IQ/OQ/PQ protocol development and execution
• Comfortable working across multiple client programs and adapting to varied validation requirements
• Interest in progressing toward CAPEX/capital project management
• Excellent cross‑functional communication and stakeholder management skills