Manufacturing Technician I

Duties

Executes fundamental unit operations in Downstream manufacturing related to the manufacturing of bulk drug substance in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures. Executes independently with adequate training non-complex fundamental operations as parts cleaning, weigh and dispense, equipment prep, kits assembly, and staging. Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies. Executes with oversight of qualified staff fundamental tasks as CIP and SIP of tanks, manufactruing equipment as well as buffer prep and transfer into tanks and bags Daily analytics and maintenance of analytical equipment. Cleaning and setup of equipment. Documents work according to cGMP and cGDP. Adheres to established regulations and follows cGMP established by site. Reports abnormalities and deviations in a timely and accurate manner. Adheres to safety standards and identifies unsafe situations / habits and escalates approriately. Maintains production areas according to predefined standards (5s).

Skills

Working in a highly regulated enviroment following all applicable Client SOPs, OCPs and BGSs for cGMP, EHS and Compliance policies. Required to work according to given schedules in a 24/7 shift structure and flexibility to adapt working schedule upon prior given notice. Low to moderate - strong focus on execution of repeatable tasks with moderate technical complexity. Performing highly proceduralized tasks. Basic interactions Manufacturing Cell Culture, Manufacturing Purification, Manufacturing Compliance, Engineering & Technology, Supply Chain, Quality Assurance, Quality Control Does not require extensive technical knowledge of manufacturing operations. Low impact, repeatable, highly proceduralized.