Process Engineer I - $8,000* Sign On

Kite Pharma
Frederick, MD
Nov 24, 2021
Nov 26, 2021
Engineer, IT, QA Engineer
Full Time
Job DescriptionEveryone at Kite is grounded by one goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!Kite, a Gilead Company, is a biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient's own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team.We are seeking a highly motivated individual to join us as an Equipment Engineer supporting our manufacturing facility in Frederick, MD. In this role, you will be a key contributor to the operation of our MFG organizationKey responsibilities:Equipment Engineer supporting the licensure and operation of a fully automated cell therapy manufacturing facilityEvolving Subject Matter Expert for cell therapy QC analytical, QC micro and MFG process equipment.Responsible for developing and maintaining Asset Life Cycle Management, including equipment records, spare parts lists, maintenance and calibration plans.Specify procure and install new assets into the facility. Modify facility as needed to support new assets including space planning and utility planning.Support investigation and identify root cause for critical equipment and determine CAPAParticipate in evaluation of new technology and automation for introduction into the Quality Control labs and MFG suites to improve efficiency, reliability and reduce cost.Work with vendors and corporate to define equipment requirementsWrite and review technical documentation (batch records, SOPs, protocols & reports for FATs, SATs, IQ/OQ/PQ testing, comparability, aseptic process and cell therapy manufacturing process validation testing)Executes change control and change management including cost and change justificationRun Capital Projects supporting increased infrastructure and capacityMay coordinate contract personnel through completion of assignmentsBasic Qualifications:Master's Degree and ORBachelor's Degree and 2+ years' experience in cGMP commercial manufacturing and regulatory requirements ORAA Degree and 4+ years' experience in cGMP commercial manufacturing and regulatory requirements ORHigh School Degree and 5+ years' experience in cGMP commercial manufacturing and regulatory requirementsPreferred Qualifications:Understanding of basic engineering principlesDegree in Biochemical Engineering, Chemical Engineering, or BiotechnologyExperience with QC analytical and microbial equipment for a commercial cell therapy manufacturing facilityDemonstrated troubleshooting and problem-solving skills with GMP process equipment and QC equipmentData trending and analysis for GMP process equipment and QC equipmentPrevious experience with cell therapy products is a plusUnderstands and employs principles and concepts of Lean Six Sigma to improve process capabilityEvolving knowledge of commercial manufacturing of biotechnology products, aseptic processing, cell therapy productionAbility to generate, read and interpret drawings such as PFDs, floor plans, P&IDs and electrical schematicsExcellent interpersonal, verbal and written communication skillsEager to rapidly learn and apply problem solving skills to new situationsSelf-motivated and willing to accept responsibilities outside of initial job descriptionWell-developed computer skillsDoes this sound like you? If so, please apply today!This Position qualifies for a $8,000 Sign-on Bonus, $4,000 payable within 30 days of start date and $4,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue. Applies to external hires only.#FAC123MD