Senior Engineer, CSV Validation

Job Description

Job Title:

Senior Engineer, Validation CSV

Reports to Senior Manager, Validation-CSV

Department:
Corporate Quality

Hours:

Monday - Friday (core office hours), hybrid

Location:

Stevenage, UK

Autolus 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.

Our team is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and autoimmune diseases to 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.

Autolus 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.

This 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. There 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.

• Perform validation activities as directed on projects including defining the validation requirements to ensure compliance with MHRAs Orange Guide, EU's Eudra Lex Vol. 4, USA's CFRs, ISO, ICH, GAMP and PIC/S.
• CSV Engineer is able to perform computer systems validation who will implement best practices for system implementation as per GAMP 5 guidance.
• Support 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.
• Perform computerised system validation by authoring & execution of CSV documentation with relevant stakeholders ensuring timelines are met and deliverables achieved.
• Perform CSV assessments for data integrity, electronic records/electronic signatures, using guidance from GAMP5 / 21 CFR categorisation requirements.
• Perform vendor assessments as required for projects where applicable.
• Assist in the development and maintenance of validation-related procedures & policies.
• Perform 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.
• Assist in the training of CSV requirements…