Pay: $28 - $32/HourDuration: 1 yearMonday to Friday, 5X8, 8:00-5:00Position SummarySeeking an energetic and experienced individual with method automation background to join our Quality Control (QC) team. The Automation Engineer/Analyst, QC Analytical will lead the effort of validating automated workflows for dPCR and Flow cytometry methods.This role will work within the QC Analytical team and collaborate with IT, Analytical Sciences, and facility teams to validate the CAR percentage and Vector Copy Number methods for our late‑phase cell therapy product. The successful candidate will lead the team to transition from our manual assays into compliant, high‑throughput automated processes within a regulated cGMP environment.ResponsibilitiesPerform automated dPCR, flow cytometry, and other supporting procedures to validate the methods and enable the release testing and stability monitoring of cell therapy products and in‑process samples.Support technical transfer from Analytical Development, receive analytical method training, pre‑qualification tests, and validation executions.Act as a subject matter expert in technical discussion, document review, and investigations.Prepare departmental SOPs, technical documents, undertake investigations, and draft trouble‑shooting plans.Support quality events (change control, deviations and CAPA), QC Operations, including LIMS implementation, equipment qualification, maintenance and calibration, and Sample Management.Perform other duties as requested by supervisor to support the implementation of automated methods.Author and/or review analytical test results, technical and regulatory documents including but not limited to analytical study data summaries and reports, analytical method validation protocols, and standard operating procedures (SOP).QualificationsHands‑on experience with laboratory automation platforms and automated workflow integration of analytical methods in QC or AD environment.Experience supporting automated liquid handlers such as Hamilton, Duet, Tecan, or similar systems.Understanding of QC workflows and sample processing operations.Experience leading or supporting automation integration and cross‑functional technical projects.Familiarity with quality systems such as Veeva and working knowledge of cGMP environments, quality events (change control, deviations and CAPA) and data integrity expectations.Preferred QualificationsExperience in Hamilton and/or other cGMP automatic liquid handling instruments for QC assays.Experience in various cell therapy analytical techniques including Flow cytometry and dPCR.Education and ExperienceB.S. in Immunology, Cell Biology, Bioengineering, Analytical Sciences, or a related scientific discipline with 2+ years of relevant hands‑on experience orM.S. in Immunology, Cell Biology, Bioengineering, Analytical Sciences, or a related scientific discipline with 1 year of prior industry experience required.#J-18808-Ljbffr
The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.