Manufacturing Associate III - Downstream

Position Overview The Manufacturing Associate III executes manufacturing processing steps and associated activities while maintaining strict adherence to Current Good Manufacturing Practice (CGMP), quality and regulatory standards. Flexibility with working hours and shift rotation is essential to effectively support the 24/7 manufacturing facility. Job Responsibilities Executes and documents manufacturing processing steps or support activities, process monitoring, and control within at least one functional area in manufacturing (e.g., Fermentation, Purification, Recovery, Cell Culture) and all support functions (e.g., Glasswash, Buffer/Solution Prep). Performs in-process sampling and testing (e.g., pH, conductivity, visual inspection). Executes validation protocols according to CGMP standard operating procedures (SOPs). Maintains training to perform all required activities. Performs manufacturing task execution using all applicable areas of Distributed Control Systems (DCS) (Delta V, 800xA, Unicorn, etc.). Conducts takeouts, identity check returns and other tasks in Manufacturing Execution System (MES). Performs clean‑in‑place (CIP), steam‑in‑place (SIP) and other equipment cleanings. Performs other duties as assigned. Knowledge, Skills, and Abilities Effective communication, both written and verbal. Knowledge of CGMP and safety regulations. Ability to work in a team environment. Time management skills and detail‑oriented. Ability to initiate a deviation and a work order within the Computerized Maintenance Management System (CMMS). Must support a 24/7 manufacturing facility working shift (2‑2‑3 day/night). Minimum Education and Experience Requirements High School Diploma/GED with 4+ years of experience in a CGMP manufacturing environment; or Associate degree in life science, engineering, or relevant technical field with 2+ years of experience in a CGMP manufacturing environment; or Bachelor's degree in life science, engineering, or relevant technical field with no prior experience; or Equivalent Military training or experience. Preferred Education, Certification, and Experience Requirements Experience with unit operation (e.g., Cell Culture, Fermentation, etc.). BioWork certificate. Physical Requirements Will work in environment which may necessitate respiratory protection. Ability to discern audible cues. Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. Ability to ascend or descend ladders, scaffolding, ramps, etc. Ability to stand for prolonged periods of time up to 240 minutes. Ability to sit for prolonged periods of time up to 240 minutes. Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. Ability to conduct work that includes moving objects up to 33 pounds. Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. Will work in warm/cold environments. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre‑employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (View email address on click.appcast.io). #J-18808-Ljbffr Merck & Co.