Technical WriterUnited States - California - El SegundoManufacturing Operations & Supply ChainRegular
Kite is seeking to cure cancer by applying cutting edge technology in the field of cell therapy. We are the leader in producing licensed therapies. We are seeking a highly motivated individual to join us as a Technical Writer at our TCF03 facility located in El Segundo, CA. You will be part of the validation department reporting to the Manager of Validation, but you will be a hands-on resource for the entire Facilities and Engineering (F&E) department.
Responsibilities (include but are not limited to):
You will be responsible for working with Subject Matter Experts (SMEs) to translate engineering documentation into the life cycle documents (SOPs, Functional Specs, work plans, test scripts, etc.) required to keep Kite’s TCF03 facility running and in compliance with all applicable regulations.
You will be responsible for administering all aspects of the Quality Management System (QMS) as it relates to engineering. You will work with SMEs to get all needed data into the QMS to efficiently and punctually open and close CAPAs, Deviations, Change Controls, Audit responses, etc. as required by the Facilities and Engineering department.
You will be a continuous improvement champion for the department. You will be an active participant in seeking to make the F&E department better at all aspects of its operations.
You will be the QMS expert for the F&E department.
· Master’s degree with 2+ years of experience in quality, engineering, manufacturing and biotech/pharma OR
· Bachelor’s degree with 4+ years of experience in quality, engineering, manufacturing and biotech/pharma OR
· AA degree with 5+ years of experience in quality, engineering, manufacturing and biotech/pharma OR
· High School degree with 6+ years of experience in quality, engineering, manufacturing and biotech/pharma
BS in engineering or related field and 3+ years of experience in an FDA regulated industry.
A working knowledge of the cGMPs and documentation practices required to maintain compliance to the cGMPs
A working knowledge of the key components of a cGMP QMS like CAPAs, Deviations, life cycle documents and all necessary approvals
Familiarity with common QMS systems like Veeva, Trackwise, IsoTrain, etc
Able to read and interpret technical documents such as blueprints, PFDs, P&IDs, O&M manuals,
You will have excellent listening skills that will to allow you to gather all information necessary to create clear and concise QMS documentation. You will have excellent writing skills that allow you to clearly communicate all the information you gather across all functions (QA, QC, Manufacturing, Supply Chain, IT).
Must be able to function and contribute as part of a team, have excellent communication skills and contribute to team-based decisions.
Ability to think critically with demonstrated troubleshooting and problem-solving 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 and fluent with Microsoft office applications.
experience writing maintenance work plans
Equipment Validation experience (IOQ).
Computer System Validation (CSV) experience.
Some automation experiences.
Some experience with cell culture and better if it is with a cell therapy.
Some experience with process validation.