At a Glance
- Tasks: Lead validation activities for innovative cancer therapies and ensure compliance with industry standards.
- Company: Join Autolus, a pioneering biopharmaceutical company transforming cancer treatment.
- Benefits: Enjoy a competitive salary, performance bonuses, and a comprehensive benefits package.
- Other info: Flexible hybrid working model and opportunities for professional growth.
- Why this job: Make a real difference in patients' lives while working in a dynamic and inclusive environment.
- Qualifications: 5+ years in validation within biopharmaceuticals and strong technical writing skills required.
The predicted salary is between 51750 - 63250 £ per year.
Work with us. Our team is 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.
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. Autolus has a pipeline of product candidates in development for the treatment of haematological malignancies, solid tumours, and autoimmune diseases.
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.
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.
- 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.
- Assist in the development and maintenance of validation-related procedures & policies.
- 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.
Demonstrated skills and competencies:
- Prior experience of Validation within biopharmaceutical or pharmaceutical manufacturing environment (Minimum of 5+ years in Validation Engineer role).
- Specialist knowledge of CSV derived independently through both practical experience and theoretical studies.
- Experience developing and execution of computerised system validation test protocols & validation lifecycle documentation.
- Strong technical writing and communication skills.
- Experience of having supported FDA, MHRA, EMA or any other regulatory Audit inspections.
Qualifications: Minimum of degree in computer science or a related scientific or technical discipline, or equivalent relevant experience.
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.
Senior Engineer, CSV Validation in Stevenage employer: Autolus Therapeutics
Autolus Therapeutics is an exceptional employer that fosters a culture of innovation and collaboration, making it an ideal place for professionals in IT Infrastructure and Cyber Security. Located in a dynamic environment, employees benefit from comprehensive growth opportunities, competitive compensation, and a commitment to work-life balance, all while contributing to cutting-edge advancements in healthcare technology.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Engineer, CSV Validation in Stevenage
✨Get Involved in Local Research Communities
Tap into local biotechnology meetups and research forums. These are great places to mingle with industry professionals, share your passion, and even discover unadvertised job openings. It's all about getting your face known in the field!
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✨Show Off Your Projects
Curate a portfolio showcasing any research projects or internships you've completed in biotechnology. This tangible evidence of your skills can really impress employers when you chat with them at networking events or interviews. It's about making that killer first impression!
✨Stay Up-to-Date with Industry Trends
Biotech is a fast-paced field, so keeping yourself updated with the latest advancements is crucial. Attend industry conferences, webinars, or workshops to broaden your knowledge and meet potential employers. Plus, it’ll give you fantastic talking points for your interviews at places like Autolus Therapeutics!
We think you need these skills to ace Senior Engineer, CSV Validation in Stevenage
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show Autolus Therapeutics that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at Autolus Therapeutics.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that Autolus Therapeutics does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at Autolus Therapeutics
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at Autolus Therapeutics. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into Autolus Therapeutics's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at Autolus Therapeutics. This shows your passion for the industry!
