Site Validation Lead - GxP, EU GMP Expert

Curaleaf International; Sunderland; On-site; GBP 70,000 - 90,000; Full time

Benefits offered by this job

On-site parking

Job summary

Curaleaf International is seeking an experienced Validation Lead for Sunderland to own and drive the site-wide validation programme across facilities, utilities, equipment and automated systems. You will lead planning, execution and ongoing maintenance in line with EU GMP Annex 15 and ICH Q9, acting as the site SME and coordinating with Manufacturing, Engineering, IT and QC teams.

The role involves ensuring qualification activities are planned, executed, documented and inspection-ready, with

Qualifications

• Degree (or equivalent) in a relevant scientific or engineering discipline.
• 5+ years' experience within GxP pharmaceutical manufacturing.
• Equipment and utility qualification (DQ/FAT/SAT/IQ/OQ/PQ).
• Process and cleaning validation.
• Automation, control systems or computerised system validation (Annex 11 / GAMP 5).
• Strong working knowledge of EU GMP Annex 15, Annex 11 and ICH Q9.
• Experience within a formal pharmaceutical quality system—change control, deviations, CAPA, document control and data integrity.
• Strong technical writing skills—able to produce clear protocols/reports and defend validation strategy during inspections.
• Experience within CBPM, specials or small-batch manufacturing environments.
• Previous experience as a Site Validation Lead or CSV Lead.
• Direct involvement in regulatory inspections (MHRA, FDA or equivalent).
• Familiarity with data integrity principles and electronic record systems.

Responsibilities

• Develop, maintain and coordinate delivery of the Validation Master Plan (VMP), validation strategy and inventory across the site.
• Lead qualification activities including URS, DQ, FAT, SAT, IQ, OQ and PQ for facilities, utilities, production equipment and automated systems.
• Prepare, review and approve validation plans, risk assessments, protocols, reports and traceability documentation.
• Apply EU GMP Annex 15, Annex 11, GAMP 5 and ICH Q9 to define validation scope and testing approaches.
• Coordinate process validation, cleaning validation and analytical method verification activities.
• Act as site SME, providing technical guidance to Manufacturing, Engineering, IT, QC and Supply Chain teams.
• Assess change controls and deviations for validation impact; define re-qualification or revalidation requirements.
• Track and close validation actions from changes, deviations, CAPAs, audits and inspections.
• Support capital projects, equipment installations, technology transfers and new product introduction with full lifecycle validation input.
• Review deliverables from external contractors and suppliers to ensure GMP compliance.
• Maintain validation records and status tracking — ensuring full documentation is complete and inspection-ready.
• Deliver validation-related training and support continuous improvement of processes and procedures.
• Monitor validation KPIs and report progress, risks and overdue activities to the Head of Projects and Facilities.

Skills

Technical leadership

Cross-functional collaboration

Regulatory compliance

Documentation

Education

Degree in scientific/engineering discipline

Job description

Curaleaf International is seeking an experienced Validation Lead for Sunderland to own and drive the site-wide validation programme across facilities, utilities, equipment and automated systems. You will lead planning, execution and ongoing maintenance in line with EU GMP Annex 15 and ICH Q9, acting as the site SME and coordinating with Manufacturing, Engineering, IT and QC teams.

The role involves ensuring qualification activities are planned, executed, documented and inspection-ready, with