{"id":62801,"date":"2026-08-20T00:00:00","date_gmt":"2026-08-19T23:00:00","guid":{"rendered":"https:\/\/www.desiblitz.com\/jobs\/job\/process-validation-lead\/"},"modified":"2026-08-20T04:20:24","modified_gmt":"2026-08-20T03:20:24","slug":"process-validation-lead","status":"publish","type":"job_listing","link":"https:\/\/www.desiblitz.com\/jobs\/job\/process-validation-lead\/","title":{"rendered":"Process Validation Lead"},"content":{"rendered":"<p><strong>Process Validation\u00a0Lead\u00a0<\/strong><\/p>\n<p><strong>Location:\u00a0Northern Ireland\u00a0<br \/>\nType:\u00a0Full Time, Permanent\u00a0<\/strong><\/p>\n<p><strong>The Opportunity\u00a0<\/strong><\/p>\n<p>We are seeking an experienced\u00a0Process Validation\u00a0Lead\u00a0to join a growing pharmaceutical manufacturing organisation. This is a key technical role supporting the transfer of new products into commercial manufacturing, while also providing ongoing lifecycle support for established products.\u00a0<\/p>\n<p>The successful candidate will bring strong\u00a0expertise\u00a0in\u00a0process validation, technology transfer, GMP compliance, and manufacturing support, working cross-functionally across Pharmaceutical Development, Technical Services, Engineering, Quality, Regulatory Affairs and Manufacturing Operations.\u00a0<\/p>\n<p><strong>Key Responsibilities\u00a0<\/strong><\/p>\n<ul>\n<li>\n<p>Lead and support process validation activities across development and commercial manufacturing programmes.\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Prepare,\u00a0review\u00a0and approve validation protocols, reports, SOPs, master plans and supporting technical documentation.\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Collaborate with Process Development, Technical Services, Engineering, Health &amp; Safety and Quality teams to\u00a0establish\u00a0robust process control strategies.\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Support equipment qualification activities, process performance qualification (PPQ)\u00a0studies\u00a0and associated risk assessments.\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Review manufacturing process documentation to ensure alignment with approved formulations and regulatory submissions.\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Provide technical\u00a0expertise\u00a0during investigations relating to deviations, CAPAs, out-of-specification (OOS) and out-of-trend (OOT) results.\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Support the introduction of new products into manufacturing and provide technical oversight throughout technology transfer activities.\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Act as a subject matter expert for validation activities, including:\u00a0\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Manufacturing process validation\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Packaging process validation\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Cleaning validation\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Equipment qualification\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Facility and computerised system validation\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Provide technical support to Regulatory Affairs on validation-related matters.\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Participate in project and customer meetings to ensure projects\u00a0remain\u00a0aligned with agreed timelines and\u00a0objectives.\u00a0<\/p>\n<\/li>\n<\/ul>\n<p><strong>Essential Requirements\u00a0<\/strong><\/p>\n<ul>\n<li>\n<p>Degree qualified in a Scientific, Pharmaceutical,\u00a0Engineering\u00a0or related discipline.\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Experience working within a GMP-regulated pharmaceutical or life sciences environment.\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Practical experience of process validation and associated regulatory requirements.\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Experience authoring and reviewing technical documentation, including protocols and reports.\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Strong understanding of data interpretation, investigation processes and risk-based decision making.\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Working knowledge of VICH guidelines.\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Proficient in Microsoft Office applications.\u00a0<\/p>\n<\/li>\n<\/ul>\n<p><strong>Desirable Requirements\u00a0<\/strong><\/p>\n<ul>\n<li>\n<p>Process Engineering or Chemical Engineering background.\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Experience supporting technology transfer and scale-up activities.\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Previous\u00a0experience transferring products from development into commercial manufacture.\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Experience across multiple pharmaceutical dosage forms.\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Additional\u00a0experience within pharmaceutical development, technical\u00a0services\u00a0or manufacturing support functions.\u00a0<\/p>\n<\/li>\n<\/ul>\n<p><strong>Additional Information\u00a0<\/strong><\/p>\n<ul>\n<li>\n<p>This manufacturing facility handles penicillin products. Therefore, the role may not be suitable for individuals with a penicillin allergy.\u00a0<\/p>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<p>Applicants must have the right to work in the UK at the time of application.\u00a0<\/p>\n<\/li>\n<\/ul>\n","protected":false},"author":1,"featured_media":62802,"template":"","meta":{"_promoted":"","_job_location":"Newry, Newry Mourne and Down","_application":"https:\/\/www.cv-library.co.uk\/job\/225515261\/Process-Validation-Lead?s=103904","_company_name":"Next Phase Recruitment Limited","_company_website":"https:\/\/www.cv-library.co.uk\/list-jobs\/211271\/Next-Phase-Recruitment-Limited","_company_tagline":"","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary_currency":"","_job_salary_unit":""},"job-categories":[],"job-types":[685],"job_listing_tag":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Process Validation Lead | DESIblitz Jobs<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.desiblitz.com\/jobs\/job\/process-validation-lead\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Process Validation Lead | DESIblitz Jobs\" \/>\n<meta property=\"og:description\" content=\"Process Validation\u00a0Lead\u00a0 Location:\u00a0Northern Ireland\u00a0 Type:\u00a0Full Time, Permanent\u00a0 The Opportunity\u00a0 We are seeking an experienced\u00a0Process Validation\u00a0Lead\u00a0to join a growing pharmaceutical manufacturing organisation. 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