{"id":2453032,"url":"https://alion.io/job/norgine-csv-engineer-12-months-ftc","title":"CSV Engineer- 12 months FTC","company":{"id":679155,"name":"Norgine","domain":"norgine.com","url":"https://alion.io/company/norgine","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workable","truth_index":{"grade":"A","score":97,"open_postings":3,"ghost_share":0,"stale_share":0.333,"repost_share":0,"time_to_fill_p50_days":17,"computed_at":"2026-10-20T05:45:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":null,"employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Hengoed, United Kingdom"],"countries":["GB"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":41000,"max_usd":86000,"period":"year","method":"role_country_seniority_unknown","sample_n":765},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-13T15:21:06Z","employer_posted_date":"2026-10-13","last_verified_at":"2026-10-20T04:26:03Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"Want a 3D career? Join Norgine.\nAt Norgine, our colleagues Dare to be different, Drive to achieve their goals and Develop themselves and their community. This is what we call a 3D career, offering ongoing development within a supportive and inclusive environment.\nNorgine: Transforming Healthcare, Backed by Over a Century of Expertise.\nWe have an exciting opportunity for a Computer Systems Validation Engineer to join Norgine in Hengoed.\nThe Role:\nIn this role, you will help ensure that Norgine’s GxP-regulated computerised systems, equipment, validation documentation and associated processes meet applicable quality and regulatory requirements. You will provide practical validation expertise throughout the system lifecycle and apply risk-based principles to support compliance, data integrity and operational effectiveness.\nThis is a 12-month fixed-term contract (FTC) role\nRequirements\nKey Responsibilities:\nPlan, coordinate and carry out validation activities for new and existing GxP-regulated computerised systems.\nDevelop, review and maintain validation plans, risk assessments, protocols, test scripts, reports and traceability matrices.\nPerform system testing and verification to confirm that systems meet defined business, quality and regulatory requirements.\nSupport audits, inspections and regulatory enquiries by providing validation evidence.\nWork with Quality, Manufacturing, Engineering, IT and external vendors to assess changes and embed validation requirements throughout the system lifecycle.\nContribute to validation standards, processes, best practice and continuous improvement.\nSkills and experience required\nA bachelor’s degree, or equivalent qualification or experience, in computer systems, engineering or a related discipline.\nExperience working with relevant procedures or systems.\nCompetence in quality assurance methodologies, review and reporting, data collection and analysis, planning and organisation, requirements verification and project quality management.\nAbility to interpret complex information, make sound decisions and identify appropriate actions.\nStrong collaboration and communication skills, with the confidence to raise compliance concerns when required.\nA structured, accountable approach to documentation, testing and delivery.\nBeneficial experience\nWorking knowledge of GxP requirements, data-integrity principles and relevant guidance, including GAMP 5, EU GMP Annex 11 and 21 CFR Part 11.\nExperience producing and executing validation deliverables, including risk assessments, protocols, test scripts and validation reports.\nFamiliarity with manufacturing, laboratory, quality, ERP, MES, LIMS or other regulated computerised systems.\nBring our values to life\nDrive: Take ownership, focus on business priorities and deliver results.\nDare: Challenge respectfully, explore new ideas and address difficult issues constructively.\nDevelop: Build strong connections, collaborate across teams and value different perspectives.\nWhy join us?\nAt Norgine, you’ll join an inclusive environment where different perspectives are valued. You’ll have opportunities to develop your career while contributing to work that makes a meaningful difference to patients’ lives.\nApply through LinkedIn or the Norgine careers page.\nThis job advert is a summary of the typical functions of the job not an exhaustive or comprehensive list of all possible responsibilities, tasks, and duties. Norgine reserves the right to change responsibilities to meet business and organisational needs, as necessary.\nAI Transparency Statement:\nTo help us create clear and engaging job adverts, we may use AI-assisted drafting based on an approved job description. Every advert is reviewed and approved by our recruitment team before publication to ensure it accurately reflects the role and our organisation.\nBenefits\nOur benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.\nSound good? 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