The Sr. Technician is a hand-on, non-exempt position, responsible for assisting in the scheduling, coordinating, supervising, training, and reviewing the work of manufacturing teams assigned to perform a variety of operations, supply chain and manufacturing duties. Some examples are: receiving of incoming purchased items, inventory cycle counting and organization, manufacturing and testing of material in a GMP environment, and manufacturing and testing of R&D material. Ability to comply with Safety procedures and to adhere to GMP requirements regarding documentation, supply chain activities, and manufacturing are critical aspects of this role. Ability to devise ideas for process improvements relating to supply chain, manufacturing, documentation and clean room environment is a must. Must be able to adapt to changing goals and requirements. Must be comfortable with and able to learn new tasks and responsibilities. The position is accountable for ensuring safety, the correct and safe use of equipment and the adherence to all GMP objectives and other applicable requirements. Sr. Technicians are working technicians and are assigned to run processes, complete documentation, etc. as well as learn new tasks and be open to new goals and objectives.
• Must be regular and punctual in attendance and adhere to all Trelyst employee handbook policies.
• Accurately completes all documentation: batch records, forms, equipment, facility logs, and labels.
• Supply Chain:
o Performs receiving, inventory, and warehousing functions
o Performs materials and components receiving, sampling, and identity testing
o Maintains raw-material records and internal inventory tracking including accepted, quarantined and rejected materials to ensure proper utilization and accounting of materials
o Prepares facility and equipment for manufacturing start-up. Monitors and controls manufacturing processes.
o Manufactures, labels, and packages silicone excipient and API’s under cGMP requirements
o Performs equipment and facility cleaning, maintenance, and calibration
• Provides or coordinates training of new and existing operators in areas such as, but not limited to safe work techniques, time-saving methods, use and documentation of run sheets, and identification of safety concerns. Works with employees to learn additional skills and correct deficiencies
• Perseveres through various working conditions to complete tasks and projects. Takes appropriate measures to meet department needs and timelines, and to address team shortcomings. Provides work direction and appropriate feedback through multiple communication channels as deemed appropriate.
• Develops personal strategies for juggling competing demands. Examines the impact of current and/or upcoming changes on the work group processes and provides direction to others on adjusting accordingly.
Knowledge of process production activities in a chemical or mechanical manufacturing environment, H.S. graduate with a minimum of 5-year experience in silicone, excipient and/or API manufacturing; A.A. in Chemistry or other physical sciences with a minimum 3-year experience in silicone, excipient and/or API’s manufacturing; B.A. or B.S degree in Chemistry or other physical sciences with a minimum 1-year experience in silicone, excipient, and/or API’s manufacturing ; Working knowledge of functions within a typical business supply chain (e.g., shipping, receiving, order procurement / purchasing, scheduling and execution) required. Excellent oral and written skills. Computer literate (MS WORD/EXCEL). Knowledge of cGMP, ISO, OSHA, HazWoper, and other governmental regulatory requirements preferred. Prior experience with silicone manufacturing using mixing, compounding, and molding equipment preferred.