{"id":2084398,"url":"https://alion.io/job/autolus-senior-engineer-csv-validation","title":"Senior Engineer, CSV Validation","company":{"id":1964865,"name":"Autolus","domain":"autolus.com","url":"https://alion.io/company/autolus","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Stevenage, United Kingdom"],"countries":["GB"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":61000,"max_usd":97000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":104},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GDPR","optional":false},{"name":"Incident Management","optional":false}],"status":"live","first_seen_at":"2026-08-20T00:00:00Z","employer_posted_date":"2026-08-20","last_verified_at":"2026-10-11T01:30:29Z","board_verified":true,"closed_at":null,"days_open":52,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":52},"description":"Work with us\nOur team are passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and Autoimmune disease to deliver life-changing treatments to patients.\nWhilst working at Autolus you will enjoy a flexible, diverse and dynamic working environment which actively promotes creativity, leadership and teamwork - together we are ONE Autolus.\nJob Description:\nJob Title: Senior Engineer, Validation CSV\nReports to Senior Manager, Validation-CSV\nDepartment: Corporate Quality\nHours: Monday - Friday (core office hours), hybrid\nLocation: Stevenage,UK\nAbout Autolus\nAutolus is a biopharmaceutical company, advancing innovative therapies at both clinical and commercial stages of development, focused on next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled, and highly active T cell therapies designed to better recognize cancer cells, break down their defence mechanisms, and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of haematological malignancies, solid tumours, and autoimmune diseases.\nWhy Autolus\nOur team is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and autoimmune diseasesto deliver life-changing treatments to patients. Whilst working at Autolus you will enjoy a flexible, diverse, and dynamic working environment which actively promotes creativity, leadership and teamwork. In addition to this Autolus is proud to offer a competitive salary, performance related bonus as well as a comprehensive benefits package.\nOur Promise\nAutolus is developing complex, breakthrough therapies for a globally diverse market and equally recognises that diversity amongst our people is critical to our mission. As we draw on our differences, what we’ve experienced, and how we work, we celebrate diversity and are committed to creating an inclusive environment for all employees.\nRole Summary\nThis is a hands-on senior engineering role with ownership across the computerised-system lifecycle, from initial GxP impact and supplier assessments through validation, release, operation, periodic review and retirement. The successful candidate will partner with Quality, Manufacturing, Engineering, IT, and system owners to deliver compliant, risk-based validation/qualification solutions that support Autolus manufacturing and testing operations.\nThere is an opportunity for a bright, enthusiastic, and experienced individual with a background in life sciences/engineering disciplines to join the Validation Team. This role is responsible for authoring, executing, reporting and maintaining validation lifecycle activities within the framework of cGMP and in compliance with the company QMS requirements for computerised/automated systems used in the manufacture and testing of Autolus products. The role will be based in Stevenage working on innovative oncology CAR-T cell therapeutics.\nKey Responsibilities\nPerform validation activities as directed on projects including defining the validation requirements to ensure compliance with MHRAs Orange Guide, EU's EudraLex Vol. 4, USA's CFRs, ISO, ICH, GAMP and PIC/S.\nCSV Engineer is able to perform computer systems validation who will implement best practices for system implementation as per GAMP 5 guidance.\nSupport authoring of User Requirement Specifications where required, and authoring and executing Validation Plans, Functional/Configuration documentation, data migration & De-commissioning plans, vendor assessments and reports, Design documentation, Installation / Operational / Performance Qualification protocols, reports, traceability matrix for validation and support user testing.\nPerform computerised system validation by authoring & execution of CSV documentation with relevant stakeholders ensuring timelines are met and deliverables achieved.\nPerform CSV assessments for data integrity, electronic records/electronic signatures, using guidance from GAMP5 / 21 CFR categorisation requirements.\nPerform vendor assessments as required for projects where applicable.\nAssist in the development and maintenance of validation-related procedures & policies.\nPerform maintenance of validated state for computerised systems (change & Incident management) and their periodic reviews of validated computerised systems. Manage CSV-related change controls, CAPAs and non-conformances.\nAssist in the training of CSV requirements to all areas of the company where required.\nParticipate and support regulatory authority inspections as a CSV subject matter expert.\nProvide updates to the line Manager and escalate any issues as they occur.\nDemonstrated skills and competencies\nE - Essential\nP - Preferred\nExperience\nPrior experience of Validation within biopharmaceutical or pharmaceutical manufacturing environment (Minimum of 5+ years in Validation Engineer role) (E)\nSpecialistknowledgeofCSVderivedindependently throughbothpracticalexperience andtheoreticalstudies.(E)\nExperience developing and execution of computerised system validation test protocols & validation lifecycle documentation (E)\nExperienceofengaging anddealing projectstakeholders and work cross functionally.(E)\nAn Understanding of CSV requirements in accordance with FDA 21CFR Part11/EU GMP Annex11 regulations and ISPE GAMP5 Guidelines (E).\nValidationprojectmanagement(P)\nFamiliarity of SaaS/Cloud based systems validation utilising modern CSA approach. (E)\nUnderstanding of validation/assurance of AI and ML enabled systems, preferably in a GxP environment. (P)\nStrong technical writing and communication skills. (E)\nExperience of having supported FDA, MHRA, EMA or any other regulatory Audit inspections. (E)\nQualifications\nMinimum of degree in computer science or a related scientific or technical discipline, or equivalent relevant experience.\nSkills/Specialist knowledge\nDemonstrate understanding of Computer Systems Validation (CSV) and Data Integrity (DI) requirements for regulated industries and its development life cycle approach (E)\nStrongtechnical authoringskills(E)\nThorough knowledge ofcGMP& GAMP asappliedinbiopharmaceuticalorrelatedindustry(E)\nProvenabilitytomeet timelines,prioritisetasksandengagewithstakeholders(E)\nGood communication skills and the ability to train people if required in CSV (E)\nAbilitytoworkwithcross functional teamsinternallyandexternallytoAutolus(E)\nAutolus Core Competencies\nFocus on Results: Works to meet business goals set by management and leaders\nBuilds Trust and Relationships: Ensures trust with internal and external partners by delivering on commitments\nResilience: Has the capacity to recover quickly from difficulties; toughness\nCommunicates and Collaborates: Builds partnerships and works collaboratively with others to meet objectives\nAutolus is committed to the protection of the personal information that we collect & process and we are fully compliant with General Data Protection Regulations (GDPR)\nAutolus is committed to providing an inclusive and fair workplace for all. We are an equal opportunity employer and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic. We also provide reasonable accommodations where appropriate.\nAutolus is committed to the protection of the personal information that we collect & process and we are fully compliant with General Data Protection Regulations (GDPR).\nAutolus is committed to providing an inclusive and fair workplace for all. We are an equal opportunity employer and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic. We also provide reasonable accommodations throughout the recruitment process.\nAutolus’ success is driven by equality and inclusion; we believe all voices are of equal value and must be heard. 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