Validation Engineer
hace 14 días
Sittingbourne
Validation Engineer / Validation Lead (12 month contract) A leading, global pharmaceutical manufacturing business is seeking an experienced Validation Engineer to support delivery of a major site validation and capital programme on a 12-month contract. This is a high-impact role within a busy engineering environment, offering exposure across equipment, utilities, facilities, and laboratory systems, with a need for hands-on execution specialists. If this capability brings with it project lead experience, this will also be valued. The Role Working as part of the Engineering function, you will support delivery of a structured site-wide validation programme, alongside capital project activity. Responsibilities will include: • Supporting delivery of the Site Validation Master Plan (SVMP), • Generating and reviewing validation / qualification documentation (IQ/OQ/PQ, FAT/SAT, etc.), • Leading or supporting execution of validation activities across manufacturing, lab, and utility systems, • Working closely with internal stakeholders to ensure GMP and regulatory compliance, • Reviewing vendor documentation and supporting supplier-led validation activities, • Participating in FATs and site-based commissioning activities where required, • Managing or supporting third-party contractors and vendors, • Owning change controls, deviations, and CAPAs linked to validation activities, • Supporting requalification, new equipment introduction, and decommissioning activities Project / Programme Exposure In addition to core validation delivery, there is scope to contribute at a more strategic level: • Supporting or leading capital project delivery (GxP and non-GxP), • Defining project scope, timelines, and deliverables, • Managing project risks, budgets, and progress reporting, • Coordinating cross-functional stakeholders and teams, • Driving project governance, change management, and close-out activities What We’re Looking For We’re open to a range of profiles, from strong delivery-focused CQV engineers to more senior, project-led professionals: • Experience in validation / CQV within GMP-regulated environments (pharma / biotech / related), • Strong understanding of validation principles across equipment, utilities, or facilities, • Experience authoring and executing validation documentation, • Ability to work effectively across cross-functional teams and stakeholders, • Confidence operating in a fast-paced, project-driven environment, • Strong communication and problem-solving skills Validation, commissioning, qualification, CQV, equipment, utilities, facilities, IQ, OQ, PQ, DQ, project, lead, FAT, SAT, engineer