Description Under the general direction of the lead and the overall direction of the supervisor, this position shall be responsible for the hands on execution of all activities in the production area. Activities include manual tasks and operation of equipment automated by Delta V. In addition to making routine revisions to documents, he/she may rewrite complex procedures or initiate new procedures as applicable. The incumbent has enough applied technical knowledge to perform complex trouble shooting tasks on manual and automated equipment. He/She has sufficient technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills. Experience in pharmaceutical manufacturing, is required and experience in plasma protein purification, particularly Albumin and Factor VIII, is recommended. 1) Perform hands-on execution of manual and automated manufacturing operations. Equipment includes centrifuges, ultrafiltration systems, chromatography columns, COP cabinets, SIP stations, and material handling devices. Manual activities include weighing and addition of chemicals, suspending solid paste, equipment cleaning, room cleaning, and equipment assembly. 2) Communicate issues related to equipment, process and compliance to the lead and supervisor. 3) Support the creation and revision of manufacturing related documents. 4) Participate in training and mentoring other operators on the floor. 5) Participate on Continuous Improvement teams and implement continuous improvement tools in the area, such as 6S visual management and standard work 6) Responsible for daily/weekly room cleaning (as needed). 7) Follow basic safety rules, SOPs, cGMP, work rules and other company’s policies. 8) Perform disposal of hazardous waste. 9) May perform other duties as assigned. Qualifications • Knowledge of cGMP manufacturing and in-depth process knowledge of related manufacturing techniques/specialties. • Thorough knowledge of laboratory and pharmaceutical production equipment including but not limited to: process tanks, analytical equipment and CIP/SIP systems. • Must be able to apply quantitative analysis to analyze process performance. • Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement. • Must be able to read and follow detailed written instructions and have good verbal/written communication skills. Good procedural writing skills. • Knowledge of chemical and biological safety procedures. • Good computer skills, knowledge of Microsoft Word and Excel. • Automation experience using PLCs, Delta V, MES, etc • Must have demonstrated interpersonal skills and be able to work team effectively and efficiently in a team environment. • Experience operating material handling equipment such as pallet jacks and forklifts. Education and/or Experience: Bachelor’s degree (engineering or scientific discipline preferred), 2-5 years of related manufacturing experience and demonstrated knowledge of scientific principles is required. Physical Demands: • Must be able to lift, push, pull and carry up to 50 lbs. • Requires a combination of sedentary work, walking, climbing stairs, and standing with an emphasis on walking and standing. • This position requires shift, weekend and holiday work. Overtime may be required at times. • May require immunization before performing work within the manufacturing area. Working Environment: • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. Controlled environments include construction site and clean rooms. • No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the work environment. • May be working in a loud area that requires hearing protection and other protective equipment to be worn. • Will work around chemicals such as alcohol that may require respiratory protection. • Primarily inside working conditions. • Some clean room and cool/hot storage conditions.
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