Lead Manufacturing Operator

Description – Internal Janssen Pharmaceuticals, Inc. a division of the Johnson & Johnson Family of Companies, is recruiting for Lead Manufacturing Operators located in Athens, Georgia. At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Thriving on a diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion. Proud to be an equal opportunity employer. Job Description: The Lead Manufacturing Operator performs duties related to the preparation and manufacture of intermediate or finished products for Active Pharmaceutical Ingredients, Narcotic products or medical device raw material components, procedures, as supervised by quality, environmental, and safety agencies (FDA, EPA, OSHA, DEA, etc.). In addition to conducting the duties of a Manufacturing Operator, assumes responsibility for coordinating and prioritizing activities of operators on their shift on behalf of their supervisor and performing various support activities for assigned shift/plant. Key responsibilities: Coordinates and prioritizes operator activities on their shift on behalf of their supervisor to optimally lead production schedule. Monitors progress of operators throughout shift as needed. Independently operates all production processes within assigned area and optimally follows detailed instructions. Possesses a teaching level of knowledge of manufacturing equipment and chemical processing principles. Able to train operators in multiple areas in the operation of various production processes. Follows and accurately completes batch records/logs, SAP transactions and other documentation associated with all production processes to ensure efficient operations and compliance with cGMP procedures. Independently and optimally demonstrate operation of dryers, centrifuges, mills, reactors, water systems, DCS and PLC control systems and appropriately respond to alarms and interlocks. Reconfigure the plant for next process and perform comprehensive troubleshooting on production processes and various ancillary support processes; perform troubleshooting on equipment such as dryers and centrifuges as well as the ability to troubleshoot DCS/PLC controls and failure issues; resolve recurring/common problems involving tangible variables; and recognize abnormal operation of instrumentation. Demonstrate knowledge of potential failure modes for process related equipment and recommend remedial actions. Complete process sampling requirements following applicable schedules and techniques. Follow process and utility flow diagrams. Additional position requirements: Demonstrate knowledge and use of process safety management (PSM) and participates in a PSM review or audit. Identifies and recommends areas in need to attention/improvement for process redesign. Assume responsibility for the environmental effects of work performed and for the identification and recording of environmental problems as they arise. Follow all applicable aspects of the site Environmental Management System as it pertains to normal job duties. Complete RCRA training within first six months of employment and annually thereafter. Complete all regulatory training as assigned (cGMP, ISO14001, OSHA, DEA, etc.). Carries out duties in compliance with all state and federal regulations and guidelines including FDA, ISO, EPA, OSHA, and DEA. Stays in sync with all company and site policies and procedures. Complete Operator Training Program according to established guidelines. Be available for other projects or assignments as requested by management. Continuously looks for ways to simplify or improve products, services, systems, and processes to achieve business goals, e.g., improve yield, cycle time, quality, and efficiency. Makes a positive contribution through demonstration of ability to provide training to co-workers as needed and/or assigned; to improve upon current operations practices and systems; and to learn new skills, procedures, and processes. Supervisory responsibilities There are no direct reports; however, this position will assign specific tasks and responsibilities on a shift-by-shift basis based upon production schedule and priorities. Qualifications Education: High school diploma required. Vocational, Certificate, Technical or Associates preferred. Experience and Skills: Required: Generally, requires 6-8 years of work experience with a minimum of 18 months’ work experience in similar chemical, pharmaceutical, or industry that stays in sync with cGMP environment. Must be able to read, write, and understand Basic English and read and interpret documents such as safety rules, operating and maintenance instructions, government regulations and procedure manuals. Write plant/operational status description, quality and/or safety assessments, and operating procedures. Operating skills of manufacturing equipment, tools, and hand/fork trucks. Basic math skills such as add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals required. Compute rate, ratio, and percent and draw and interpret bar graphs. Ability to calculate figures and amounts such as proportions, percentages, area, and volume. Ability to perform conversions from metric units to English units and vice versa. Demonstrated PC navigation skills such as the ability to enter data into programs/software applications and use software applications for mail, word processing, spreadsheets and other job specific needs. Able to run various reports and perform analysis of data, graphs, and trends using computer programs. Ability to follow and interpret a variety of instructions furnished in written, oral, diagram, or schedule format. Ability to solve practical problems and look after a variety of concrete variables in situations where only limited standardization exists. Ability to communicate and effectively work as part of a team. Perform a variety of tasks, paying attention to detail, without a loss of production. Lead others in the use of DCS/PLC, SAP, and other computer systems. Preferred: A minimum of 6 months of work experience in chemical, pharmaceutical, or other industry that follows cGMP environment. Operating skills of manufacturing equipment, tools, and hand/forks trucks preferred. Knowledge of DCS and SAP systems. Basic PC navigation such as the ability to enter data into programs/software applications as instructed and use software applications for mail, word processing, spreadsheets and other job specific needs highly preferred. Other: Must be willing and able to meet the physical demands of this job which include standing, walking, climbing, bending, stopping, reaching with hands and arms, and using hands to finger, handle or feel; frequently required to talk, hear, taste and smell; must have the ability to work from ladders or platforms up to 30 feet in the air and the ability to lift, push or pull up to 40 lbs. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and ability to adjust focus. Must be able to qualify for respiratory protective equipment use. While working in this job the employee is frequently exposed to outside weather conditions including extreme heat and cold. Must be willing and able to work overtime as needed. Ability to work rotating 12-hour shifts required which may include days and/or nights, in support of continuous operations. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability Primary Location United States-Georgia-Athens-1440 Olympic Drive Organization Janssen Pharmaceuticals, Inc. (6062) Job Function Operations Requisition ID 2206043307W