Instil Bio (UK) has a great opportunity for a Validation Engineer to join the team in a new and important role. Reporting to the Validation Engineer Lead this role will primarily develop and execute equipment qualification, establish and maintain the GMP suite in a qualified state, and maintain QC laboratory equipment.
Instil Bio (UK) – Introduction
Instil Bio is a cell therapy company developing tumor infiltrating lymphocytes (TIL) for the treatment of solid tumor cancers. TIL are a patient’s own T cells harvested from the patient’s tumor, which are then expanded and reinfused into the patient to target and kill cancer cells. Instil is advancing its proprietary TIL manufacturing expertise, technology, and data into clinical trials, including a planned registrational study with its lead candidate and a first-in-human study of its next-generation engineered TIL. The company is led by world-class cell therapy experts and backed by premier global institutional investors.
Instil Bio UK is Instil’s rapidly-growing, Manchester UK-based subsidiary. Our Manchester subsidiary has significant R&D, process development, and clinical manufacturing capabilities, with approximately 35 staff expanding to > 100 staff. Instil Bio UK has been generating cell therapy products for patient use since 2011, including TIL products and external partner genetically engineered T cell products.
You will author written protocols before execution, provide technical support during qualification/validation and author summary reports, or technical assessments to meet regulatory requirements.
You may also support the Process Development (PD) organization with ongoing manufacturing processes, revising sampling plans, designing and executing technology transfers, and participate in comparability exercises for Instil Bio products. You may also support Process Development, Manufacturing and Quality teams and contribute to successful cell therapy product manufacturing or draft documentation for regulatory filings to advance the Instil Bio product portfolio.
Responsibilities (include but not limited to):
- Responsible for performing the validation of process equipment, lab equipment, cleanrooms, utility systems, facilities, and processes for cell therapy programs. This includes developing validation master plans with minimal supervision, preparing protocols independently, analyzing test results, and preparing reports and technical assessments
- Contributes directly to the completion of validation projects through the development of validation schedules, master plans, validation protocols and reports for systems that may be complex in nature, to support clinical manufacturing
- Coordinates validation activities with, and seeks team supports from, Validation, Development, Manufacturing, Engineering, Quality, third Parties, and other groups on validation projects to ensure validation projects are carried out on time and on budget
- Coordinates the activities of assigned validation and contract personnel and ensures the quality of completed work
- Author protocols, user requirements, reports and data summaries with input from management
- Reviews protocols, reports and data summaries generated by peers and contract personnel.
- Work with Instil Bio (UK), vendors and suppliers to define user requirements and process, equipment or room specifications
- Support investigations, identify root causes for critical deviations and determine Corrective and Preventative Actions (CAPA) during room qualification, equipment qualification, process validation, routine manufacturing, process transfer and comparability
- Write and review technical documentation (SOPs, User Requirements Specification (URS), protocols & reports for Factory or Site Acceptance Tests (FAT, SAT), IQ/OQ/PQ testing, batch records, comparability, aseptic process and cell therapy manufacturing process validation testing)
- Other duties as assigned.
To be successful as a Validation Engineer at Instil Bio (UK) in this role it is envisaged that successful applicants will possess:
- Degree in Biochemical Engineering, Chemical Engineering, Biotechnology or related discipline with at least 2 years of pharmaceutical manufacturing, technology transfer & process development experience required.
- Practical expertise with equipment qualification in a cGMP manufacturing environment (IQ/OQ/PQ)
- Experience in pharmaceutical biotechnology GMPs, validation and regulatory requirements
- Ability to think critically, and demonstrated troubleshooting and problem-solving skills
- Excellent interpersonal, verbal and written communication skills
- Ability to function efficiently and independently in a changing environment
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Well-developed computer skills
- Previous experience with cell therapy products or cell culture products is a plus
- Demonstrated knowledge of process validation, and process transfer
- Demonstrated knowledge of aseptic processing
- Demonstrated knowledge of process development and/or process comparability
- Knowledge of data management tools and statistical process controls
Remuneration and Benefits
The salaries for Validation Engineers are competitive within the Biotechnology and wider scientific sector with actual salary offered reflecting relevant qualifications and experience as well as performance at interview. Instil Bio (UK) salaries are accompanied by a competitive benefits package.
In terms of personal development you can expect access to an abundance of career development opportunity as we scale the business and need staff who are keen to grow their professional skills along with the company.
If you would like to join us as a Validation Engineer at this exciting time in our development and you think your skills and experience are a good fit for this role apply with a current CV and we’ll get back to you within a day or two.