{"id":3799277,"url":"https://alion.io/job/alten-computer-system-validation-csv-engineer","title":"Computer System Validation (CSV) Engineer","company":{"id":52934,"name":"ALTEN","domain":"alten.com","url":"https://alion.io/company/alten-com","size_band":"5000+","is_staffing_agency":false,"employer_type":"staffing","is_intermediary":false,"listed_via":null,"ats_vendor":"SmartRecruiters","truth_index":{"grade":"B","score":76,"open_postings":86,"ghost_share":0,"stale_share":0.977,"repost_share":0,"time_to_fill_p50_days":27,"computed_at":"2026-11-06T05:58:05Z"}},"role":"Biotech","role_family":"Biotech","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Galhampton, United Kingdom"],"countries":["GB"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Verification & Validation","optional":false},{"name":"21 CFR Part 11","optional":true},{"name":"CAPA","optional":true},{"name":"GMP","optional":true},{"name":"LIMS","optional":true}],"status":"live","first_seen_at":"2026-11-05T10:28:59Z","employer_posted_date":"2026-11-05","last_verified_at":"2026-11-07T00:06:49Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"ALTEN is a global engineering and technology consultancy operating across over 35 countries worldwide. We partner with industry leaders across sectors including Aeronautics, Aerospace, Defence, Naval, Automotive, Energy, Rail, IT and many more to deliver innovative engineering solutions that drive technological advancement & support sustainable transformation.\nOur teams of passionate and agile engineers work on cutting-edge projects that shape the future of technology and sustainability. At ALTEN, we empower talented engineers to innovate, solve complex challenges, and deliver impactful solutions that build tomorrow’s world-today.\nJoin us and start building tomorrow’s world today!\n As a Computer System Validation (CSV) Engineer, you will join our [Location] team to support our activities within the Pharmaceutical & Life Sciences sector. You will support the validation and compliance of GxP-regulated computerised systems across manufacturing, quality and laboratory environments. Working closely with Quality, Engineering, Manufacturing, IT and external vendors, you will ensure systems are fit for purpose, compliant with regulatory requirements and maintain the highest standards of data integrity throughout the system lifecycle.\nLocation: Wales\nOn Site: Full time\nClearance: Clearable\n Experience Level: Mid- Level (5-9 years of experience)\nKey Responsibilities:\nPlan, coordinate and execute validation activities for new and existing GxP-regulated computerised systems.\nDevelop, review and maintain validation documentation including validation plans, protocols, test scripts, risk assessments, reports and traceability matrices.\nPerform system testing, verification and validation activities to ensure compliance with business, quality and regulatory requirements.\nSupport audits, inspections and regulatory enquiries through the provision of validation documentation and evidence.\nAssess system changes and contribute to change control activities throughout the system lifecycle.\nWork collaboratively with Quality, Manufacturing, Engineering, IT and external vendors to ensure validation requirements are implemented effectively.\nSupport data integrity initiatives and ensure systems remain compliant with applicable regulations and industry standards.\nContribute to continuous improvement activities, validation procedures and best-practice standards.\n Required Skills:\nComputer System Validation (CSV)\nGxP-Regulated Environments\nValidation Planning & Execution\nRequirements Verification & Testing\nRisk Assessments & Traceability Matrices\nQuality Assurance & Compliance\nDocumentation Review & Report Writing\nData Collection, Analysis & Interpretation\nChange Control & Lifecycle Management\nStakeholder & Vendor Management\nAudit & Inspection Support\nStrong Communication & Problem-Solving Skills\nRequired Qualifications:\nA Bachelor’s or Master’s degree in Engineering, or equivalent military experience.\nExperience working within a regulated environment supporting validation, quality or compliance activities.\nExperience creating and executing validation deliverables including protocols, test scripts, risk\nDesirable Skills:\nKnowledge of GAMP 5, EU GMP Annex 11 and 21 CFR Part 11.\nExperience with regulated systems including ERP, MES, LIMS, Manufacturing Execution Systems or Laboratory Systems.\nUnderstanding of Data Integrity principles (ALCOA+).\nExperience supporting pharmaceutical, biotechnology, medical device or life sciences organisations.\nKnowledge of Quality Management Systems (QMS), deviation management and CAPA processes.\n Why join us?\nWe bring together entrepreneurial, tech-driven people to deliver innovative solutions for leading companies.\nAt ALTEN, you’ll work on exciting projects, supported by ongoing learning, mentoring, and clear career development tailored to your goals.\nJoin a passionate team and help build tomorrow, today.\nIn short you get:\nA personalised career path and a rewarding management style \nA huge diversity of engineering projects and industries\nPrivate Medical Insurance\nCycle & Tech Scheme \nEmployee assistance programme\nLife insurance & Pension Scheme\nSocial atmosphere, regular gatherings & team buildings\nFlexible way of working (role dependent)\nWe are proud to support the Armed Forces Covenant & actively encourage applications from members of the Armed Forces community, including veterans, reservists, service leavers, and military spouses/partners. We recognise the value of military skills and experience and are committed to ensuring that no applicant is unfairly disadvantaged during our recruitment and selection processes. \nALTEN is committed to fostering a diverse and inclusive workplace and values the strength that comes from a global mix of backgrounds and perspectives. We welcome applications from all suitably qualified candidates, regardless of background or protected characteristics under the Equality Act 2010. If you require any reasonable adjustments during the recruitment process, please let us know. \nThis role may require you to have or be willing to go through Security Clearance. As part of the onboarding process candidates will be asked to complete a Baseline Personnel Security Standard; details of the evidence required to apply may be found on the government website Gov.UK. If you are unable to meet this and any associated criteria, then your employment may be delayed, or rejected . 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