Overview
We are supporting a major pharmaceutical capital project in Germany and are looking for an experienced Senior Qualification & Validation Lead to drive CQV strategy and execution across facility, utilities, equipment, and systems. The role will be responsible for leading validation activities in a GMP-regulated environment from design through to operational readiness and regulatory inspection support.
Responsibilities
Lead the development and execution of the overall Qualification & Validation strategy across the project
Manage CQV deliverables including VMPs, validation plans, protocols, and summary reports
Oversee DQ, IQ, OQ, and PQ execution for equipment, utilities, facilities, and systems
Provide leadership and direction to validation teams and contractors on-site
Ensure validation activities are aligned with GMP, regulatory, and project requirements
Review and approve validation documentation, test scripts, and risk assessments
Drive risk-based validation approaches (e.g. FMEA, CSA principles where applicable)
Coordinate closely with Engineering, QA, Automation, and Manufacturing teams
Support deviation management, change control, and CAPA activities during CQV phase
Ensure readiness for regulatory inspections and audit support activities
Provide technical guidance during commissioning-to-validation handover
Requirements
Extensive experience in Qualification & Validation within GMP-regulated pharmaceutical or biotech environments
Proven leadership experience on CQV or validation workstreams within capital projects
Strong knowledge of GMP validation lifecycle (DQ, IQ, OQ, PQ)
Experience authoring and reviewing key validation documentation (VMPs, protocols, reports, risk assessments)
Strong understanding of GMP regulations and industry guidelines (EU GMP Annex 15, ISPE, GAMP 5)
Experience working across equipment, utilities, facilities, and/or computerised systems validation
Strong stakeholder management and ability to lead cross-functional teams
Experience working in fast-paced greenfield or brownfield project environments
Fluent English required; German language skills beneficial
Preferred Experience
Experience in sterile manufacturing, biologics, fill-finish, or API environments
Previous leadership on large-scale pharmaceutical facility build or expansion projects in Europe
Exposure to regulatory inspections (FDA, EMA, MHRA)
Experience with digital validation tools or paperless validation systems
Strong background in risk-based validation approaches and modern CQV methodologies
