Validation Lead

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

We are seeking an experienced Validation Lead to take ownership of our site-wide validation programme across facilities, critical utilities, process equipment, automation, computerised systems and GxP processes. You will lead the planning, execution and ongoing maintenance of validation activities in line with EU GMP Annex 15, applying a science- and risk-based approach aligned with ICH Q9. You will maintain the Validation Master Plan, act as the site subject matter expert, and work closely with cross-functional teams and external suppliers to ensure our validated state is maintained throughout the full lifecycle.

This is a key technical role at our Sunderland site, providing specialist validation expertise across projects, facilities and operational activities — ensuring all qualification and validation activities are appropriately planned, executed, documented and inspection-ready.

About Us

Curaleaf International is shaping the future of cannabis through its commitment to research and product excellence. Powered by a strong presence at all stages of the supply chain, its unique distribution network throughout Europe, Canada and Australasia brings together pioneering research with cutting-edge cultivation, extraction, and production. Amidst a rapid growth trajectory, the emphasis on quality and expertise aims to ensure the delivery of safe and legal cannabis.

Curaleaf International’s network includes a clinic, pharmacy, and laboratory in the UK; cultivation and EU-GMP processing facilities in Portugal; an EU-GMP processing, quality assurance and research site in Spain; Four 20 Pharma wholesaler and distributor in Germany; a Polish wholesaler and clinic; and the EU-GMP producer Northern Green Canada.

Curaleaf International is part of Curaleaf Holdings, Inc., a leading international producer and distributor of consumer cannabis products.

Our Values:Lead & Inspire, Commit to Win, Driven to Deliver Excellence, Customer Obsession,One Curaleaf

Key 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, critical 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 appropriate 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, controlled 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

What You'll Bring

• Degree (or equivalent) in a relevant scientific or engineering discipline — Engineering, Pharmacy, Chemistry, Chemical Engineering or related
• 5+ years' experience within GxP pharmaceutical manufacturing, with proven track record in:
• 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)
• Solid working knowledge of EU GMP Annex 15, Annex 11 and ICH Q9
• Experience working 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
• Strong analytical and problem-solving skills — able to apply science and risk-based thinking
• Technical leadership — able to coordinate cross-functional teams and influence stakeholders at all levels
• Detail-oriented but pragmatic — applying validation proportionate to risk
• Highly organised — able to manage multiple concurrent projects and priorities effectively

What We Offer

• A key leadership role within a growing regulated manufacturing site
• Working with modern facilities and a collaborative, cross-functional team
• Opportunities for professional development and technical training
• Exposure to a broad range of validation activities across facilities, utilities, equipment and systems
• Competitive salary and benefits package — commensurate with experience
• On-site parking at our Rivergreen location