JOB DESCRIPTION: This position oversees the set-up, filling, stoppering processes of the aseptic filling lines and assists with performance of any of these operations as necessary. In conjunction with department Supervisors, meets with employees at the beginning of the work shift to review work schedule assignments and posts job assignments. Also responsible for assisting with training and monitors employees to ensure that cGMP’s, SOP’s, policies and procedures are followed. Works with QA staff to correct any audit concerns in these areas. DUTIES & RESPONSIBILITIES: Sets up filling lines by aseptically connecting sterile equipment (i.e. filters, hoses, and fitting). Checks all equipment, components and procedures against batch records. Must accurately document all data and results. Feeding of glass onto turntable keeping up with the demands of production. Stopper operations: loading hopper, watching and assisting in operations, stopper tracking bowl and transfer of stoppers to Class 100 area from racks. Trayer operations: running of trayer, cleaning of fallen vials, resetting ater overtorques, keeping up with filling operations and removal of trays from trayer and transferring to flow carts. Fill check operations: monitoring of fill volumes throughout fill, placement of monitoring plates, assisting Senior Tech in measurement of tailings and batch record completion, completion of freeze dryer load sheets and all other appropriate documentation involved with fill checks. Monitoring and performing filtration operations. Transporting filled (liquid or freeze dried) product to appropriate area. Loading filled product into freeze driers as well as properly documenting tray location, thermal couple placement, and coordination with lyo department. Clean up operations after a fill include removal of all equipment, sanitization of room, removal of tailings from area and proper disposal of contaminated items according to established safety data sheets must result. Ensures that all machinery and equipment is in proper and safe working order. REQUIREMENTS: Must possess a minimum of an Associate degree however a four year College degree in science would be preferred for advancement opportunities.Requires the ability to read, write, and perform basic math calculations (addition, subtraction, multiplication, and division). Must comprehend and follow verbal and written instructions, such as cGMP’s, SOP’s, Batch Records, policies, procedures, etc. Requires one year of Sterile Filling experience with a thorough understanding of cGMP regulations and proven ability to comprehend, follow and explain verbal and written instructions. Proficiency in the use of Microsoft Office products including project planning techniques and software. Requires sound written and verbal communication skills. Must also possess excellent interpersonal skills needed to promote a harmonious working environment. Must have a thorough knowledge of requirements of Aseptic areas and other specialized areas of the facility. Requires three months training to competently meet the minimum performance standards for the job. Physical and Mental Requirements Needed to Perform Essential Functions: 1. Physical Demands / Surroundings – Duties require sustained physical effort, usually handling average weight material (up to fifty pounds). Occasional duties require handling up to 60 pounds. Constant standing and walking. Intermittent pushing, pulling, bending, reaching and lifting. Works under conditions with hazards such as working with moving machinery/equipment and potential muscle strain and handling harsh materials and chemicals. Often work has disagreeable features such as aseptic work areas, water underfoot, significant periods of exposure to heat, cold, confinement from wearing of respirator, gloving and gowning requirements. 2. Visual Demands - Must be able to read and see clearly. 3. Temperaments/Mental Requirements – Must exercise a high degree of initiative and judgement to work out problems of medium difficulty. Job entails some responsibility for preventing waste or loss of materials, as many of the products worked with are costly. Duties require frequent attention to routine repetitive work which requires constant alertness or monitoring. 4. Level of Proficiency – Job requires work with complex machinery and equipment, filling machines, flow carts, etc.), and some small tools. 5. Attendance / Schedule - Attendance requirements are based on PII general attendance policies. These physical and mental requirements represent a sampling of the physical / mental requirements considered essential to the position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed. Pharmaceutics International, Inc. (“Pii") is proud to be an Equal Opportunity Employer, including supporting applicants and employees with a disability or protected veterans, as well as any other status protected by law.