Bioprocess Technician (Contract)

Our client, a leading CDMO is seeking a Bioprocess Specialist for cell and gene therapy manufacturing processes. This position involves executing both upstream and downstream processes in a GMP-compliant cleanroom environment, with responsibility for troubleshooting, deviation management, training, and contributing to 5S and other improvement initiatives with the goal of ensuring on time delivery and right first-time execution of Manufacturing batches. You will collaborate with Operations, MSAT, Quality, and Facilities teams to ensure consistent production outcomes. ResponsibilitiesTechnical proficiency in aseptic techniques working with manufacturing equipment/instruments in open and closed systemsOrganize, coordinate, and lead production activities and ensure execution of processes in production while strictly adhering to cGMP standardsAccurately complete batch records, forms, and documentation in line with Good Documentation Practices (GDP)Work as part of a team to support the execution of daily GMP manufacturing activitiesTrain staff in processing methods, aseptic technique, and cGMP clean room operationsReview batch production records for completeness, accuracy, and to ensure cGMPs and Good Documentation PracticesInitiate and support the closure of Deviation Reports and CAPAsOther duties as assigned by managementQualificationsMinimum High School diploma or equivalent experience is required. Associates or higher degree in Biology, Life Science, or Engineering is preferred3-4 minimum years of experience in biotech or pharmaceutical manufacturing, preferably in a cleanroom environmentFamiliarity with cGMP standards and basic understanding of Good Documentation PracticesProficiency working in cGMP cleanrooms and aseptic techniquesAdvanced understanding of pipetting and micro pipettingDemonstrated ability to identify, challenge, and implement potential improvements to work proceduresAbility to work flexible hours, including nights and weekends, as schedules may shift in this start-up environmentAbility to stand for extended periods and lift up to 20 poundsStrong communication and teamwork skills, with a willingness to learn

Created: 2025-03-03