Senior Engineer, CSV Validation

Autolus Therapeutics; Stevenage; Hybrid; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

Performance-related bonus

Comprehensive benefits package

Job summary

Autolus is seeking a Senior Engineer, Validation CSV, to own the computerised-system lifecycle from initial impact assessments to retirement. You will partner with Quality, Manufacturing, Engineering, IT and system owners to deliver compliant validation/qualification solutions across Autolus manufacturing and testing operations.

This role is based in Stevenage, UK, with hybrid working. The candidate will author, execute and maintain validation documentation, perform CSV assessments for data

Qualifications

• Minimum of degree in computer science or a related scientific or technical discipline.
• 5+ years in Validation Engineer role in biopharma/pharma environments.
• Specialist knowledge of CSV and DI requirements in regulated industries.
• Experience developing and executing computerised system validation test protocols & validation lifecycle documentation.
• Experience engaging with project stakeholders and cross-functional teams.
• Understanding of CSV requirements per FDA 21CFR Part11/EU GMP Annex11 and ISPE GAMP5 Guidelines.
• Familiarity with SaaS/Cloud based systems validation (CSA approaches).
• Understanding of validation/assurance of AI and ML in GxP environments.

Responsibilities

• Own validation lifecycle activities from concept to retirement for computerised systems.
• Collaborate with Quality, Manufacturing, Engineering, IT and system owners to deliver compliant validation solutions.
• Author and execute Validation Plans, URS, configuration docs, data migration and decommissioning plans, vendor reports and traceability matrices.
• Perform CSV assessments for data integrity and electronic records/signatures per regulatory guidance.
• Manage CSV-related change controls, CAPAs and non-conformances.
• Support regulatory-inspection readiness as a CSV SME.

Skills

CSV and DI knowledge

Technical writing

Stakeholder engagement

Cross-functional collaboration

GAMP5 / cGMP understanding

Project management

Cloud/SaaS validation familiarity

AI/ML in GxP understanding

Timelines & prioritisation

Education

Degree in Computer Science or related technical discipline

Job description

Work with us
Our 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.

Whilst 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.

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

About Autolus

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.

Why Autolus

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.

Our Promise

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.

Role Summary

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.

Key Responsibilities

• Perform 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.
• 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 to all areas of the company where required.
• Participate and support regulatory authority inspections as a CSV subject matter expert.
• Provide updates to the line Manager and elevate any issues as they occur.

Demonstrated skills and competencies

E – Essential

P – Preferred

Experience

• Prior experience of Validation within biopharmaceutical or pharmaceutical manufacturing environment (Minimum of 5+ years in Validation Engineer role) (E)
• Specialist knowledge of CSV derived independently through both practical experience and theoretical studies. (E)
• Experience developing and execution of computerised system validation test protocols & validation lifecycle documentation (E)
• Experience of engaging and dealing project stake holders and work cross functionally. (E)
• An Understanding of CSV requirements in accordance with FDA 21CFR Part11/EU GMP Annex11 regulations and ISPE GAMP5 Guidelines (E).
• Validation project management (P)
• Familiarity of SaaS/Cloud based systems validation utilising modern CSA approach. (E)
• Understanding of validation/assurance of AI and ML enabled systems, preferably in a GxP environment. (P)
• Strong technical writing and communication skills. (E)
• Experience of having supported FDA, MHRA, EMA or any other regulatory Audit inspections. (E)

Qualifications

• Minimum of degree in computer science or a related scientific or technical discipline, or equivalent relevant experience.

Skills/Specialist knowledge

• Demonstrate understanding of Computer Systems Validation (CSV) and Data Integrity (DI) requirements for regulated industries and its development life cycle approach (E)
• Strong technical authoring skills (E)
• Thorough knowledge of cGMP & GAMP as applied in biopharmaceutical or related industry (E)
• Proven ability to meet timelines, prioritise tasks and engage with stakeholders (E)
• Good communication skills and the ability to train people if required in CSV (E)
• Ability to work with cross functional teams internally and externally to Autolus (E)

Autolus Core Competencies

Focus on Results: Works to meet business goals set by management and leaders

Builds Trust and Relationships: Ensures trust with internal and external partners by delivering on commitments

Resilience: Has the capacity to recover quickly from difficulties; toughness

Communicates and Collaborates: Builds partnerships and works collaboratively with others to meet objectives

Autolus is committed to the protection of the personal information that we collect & process and we are fully compliant with General Data Protection Regulations (GDPR)

Autolus 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 accommodationswhereappropriate.

Autolus is committed to the protection of the personal information that we collect & process and we are fully compliant with General Data Protection Regulations (GDPR).

Autolus 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.

Autolus’ success is driven by equality and inclusion; we believe all voices are of equal value and must be heard. Whilst operating with focus and integrity, we are committed to improving diversity and inclusion within our business and our industry.