{"id":3013833,"url":"https://alion.io/job/cai-cqv-lead","title":"CQV Lead","company":{"id":3866618,"name":"CAI","domain":"caiready.com","url":"https://alion.io/company/caiready","size_band":"501-1000","is_staffing_agency":false,"employer_type":"staffing","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"D","score":52,"open_postings":90,"ghost_share":0.711,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":97,"computed_at":"2026-11-03T05:54:40Z"}},"role":"Biotech","role_family":"Biotech","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Limerick, Ireland"],"countries":["IE"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":70000,"max_usd":164000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":137},"experience_years_min":null,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Chromatography","optional":false},{"name":"GMP","optional":false},{"name":"HPLC","optional":false}],"status":"live","first_seen_at":"2026-10-06T13:10:06Z","employer_posted_date":"2026-10-06","last_verified_at":"2026-11-03T15:37:15Z","board_verified":true,"closed_at":null,"days_open":28,"trust":{"level":"ok","repost_count":0,"flags":["company_stale"],"days_open":27},"description":"We are seeking an experienced CQV Lead to drive qualification and validation activities for a broad range of laboratory and benchtop equipment within a GMP-regulated environment. This position offers the opportunity to lead critical qualification projects, work closely with Quality, Engineering, Validation, and Laboratory teams, and play a key role in supporting both operational excellence and regulatory compliance.\nThe successful candidate will provide technical leadership across the full equipment lifecycle, from installation and qualification through ongoing compliance and continuous improvement initiatives.\nKey Responsibilities\nLead commissioning, qualification, and validation activities for laboratory and benchtop equipment within GMP environments.\nDevelop and execute qualification documentation, including IQ, OQ, PQ protocols and final reports.\nSupport the introduction of new laboratory equipment and technologies, ensuring compliance with internal procedures and regulatory requirements.\nCoordinate qualification activities with Quality, Operations, Laboratory, Engineering, and external vendors.\nManage deviations, change controls, CAPAs, and investigations related to qualified equipment.\nEnsure equipment remains in a validated state through periodic reviews, requalification activities, and lifecycle management.\nProvide technical guidance and mentorship to CQV engineers and validation team members.\nSupport internal and external audits and regulatory inspections.\nIdentify and implement process improvements to enhance qualification efficiency and compliance.\nWhat We're Looking For\nDegree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related discipline.\nExperience leading CQV or validation activities within pharmaceutical, biotechnology, or medical device manufacturing.\nStrong knowledge of GMP requirements and qualification lifecycle principles.\nHands-on experience qualifying laboratory and benchtop equipment such as:HPLC, UPLC and chromatography systems\nTOC analyzers\nUV-Vis spectrophotometers\nAutoclaves and sterilization equipment\nIncubators and environmental chambers\nBalances and weighing systems\nFreezers, refrigerators and stability chambers\nParticle counters and laboratory instrumentation\n\nExperience authoring and reviewing qualification protocols and reports.\nStrong stakeholder management and project leadership skills.\nExcellent communication and problem-solving abilities.\nOther Requirements\n\nThis is a site based role\nEligible to work in the EU without the need for visa sponsorship, now or in the future.\nWhat Success Looks Like\nYou will be the go-to CQV subject matter expert for laboratory equipment qualification, ensuring projects are delivered on schedule while maintaining the highest standards of quality, compliance, and inspection readiness.\nWhy CAI?\n At CAI, our people are at the heart of everything we do. We partner with the world's leading life sciences companies to deliver innovative projects that ultimately improve patient lives. You'll work alongside industry leading experts in a collaborative environment that supports professional growth and technical excellence.\nIf you're a CQV professional looking to contribute to a challenging pharmaceutical project while developing your career with a global consultancy, we'd love to hear from you.\nWe may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. 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